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What is the most important information I should know about Promethazine Hydrochloride and
Codeine Phosphate Oral Solution?
Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause children to stop
breathing (respiratory depression) and cause death.

Do not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to children
younger than 12 years of age, or to children younger than 18 years of age after tonsillectomy or
adenoidectomy surgery.
You should not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to
children between 12 to 18 years of age who have certain risk factors for breathing problems,
including:
recent surgery
obstructive sleep apnea
are obese
severe lung problems
other medical conditions that can cause difficulty breathing, such as neuromuscular problems
taking other medicines that cause breathing problems

You should not breastfeed during treatment with Promethazine Hydrochloride and Codeine
Phosphate Oral Solution because it may cause your child to stop breathing and cause death.
Severe drowsiness, breathing problems (respiratory depression), coma, and death can happen in
adults and children who take Promethazine Hydrochloride and Codeine Phosphate Oral Solution
with benzodiazepines, or other central nervous system depressants, including alcohol.
Avoid taking other medicines that can cause drowsiness or sleepiness, or drinking alcohol
during treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Ask
your healthcare provider for a list of these medicines if you are not sure.
Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause breathing problems
(respiratory depression) and drowsiness.

Take Promethazine Hydrochloride and Codeine Phosphate Oral Solution exactly as prescribed
by your healthcare provider. If you take the wrong dose of Promethazine Hydrochloride and
Codeine Phosphate Oral Solution you could overdose and die. See the Medication Guide
section called “How should I take Promethazine Hydrochloride and Codeine Phosphate Oral
Solution?” for important information about how to take Promethazine Hydrochloride and Codeine
Phosphate Oral Solution correctly.
Avoid driving a car or operating machinery during treatment with Promethazine Hydrochloride
and Codeine Phosphate Oral Solution.

Call your healthcare provider or get emergency medical help right away if anyone taking
Promethazine Hydrochloride and Codeine Phosphate Oral Solution, or your breastfeeding baby has
any of the symptoms below:
increased sleepiness
confusion
difficulty breathing
shallow breathing
limpness
your baby has difficulty breastfeeding

Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a safe place away from
children. Accidental use by a child is a medical emergency and can cause death. If a child
accidentally takes Promethazine Hydrochloride and Codeine Phosphate Oral Solution, get
emergency medical help right away.

What is Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

Promethazine Hydrochloride and Codeine Phosphate Oral Solution is a prescription medicine used
to temporarily treat cough and upper respiratory symptoms, including a stuffy nose (nasal
congestion) that you can have with allergies or a common cold. Promethazine Hydrochloride and
Codeine Phosphate Oral Solution contains 2 medicines, promethazine and codeine. Promethazine is
an antihistamine. Codeine is a narcotic cough suppressant.
Promethazine Hydrochloride and Codeine Phosphate Oral Solution is a federal controlled
substance (C-V) becaus e it contains codeine that can be abus ed or lead to dependence. Keep
Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a safe place to prevent misuse
and abuse. Selling or giving away Promethazine Hydrochloride and Codeine Phosphate Oral
Solution may harm others, and is against the law. Tell your healthcare provider if you have ever
abused or been dependent on alcohol, prescription medicines or street drugs
Promethazine Hydrochloride and Codeine Phosphate Oral Solution is not for children under 12
years of age.
Who should not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution?
Do not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to children younger
than 12 years of age.
Do not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to children younger
than 18 years of any age after tonsillectomy or adenoidectomy surgery.
Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you are allergic
to any of the ingredients in Promethazine Hydrochloride and Codeine Phosphate Oral Solution. See
the end of this Medication Guide for a complete list of ingredients in Promethazine Hydrochloride
and Codeine Phosphate Oral Solution.
Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you have asthma.
Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you have high
blood pressure or narrowing of blood vessels to your legs or arms (peripheral vascular
insufficiency).
Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you take a
medicine called a Monoamine Oxidase Inhibitor (MAOI).
Before you take Promethazine Hydrochloride and Codeine Phosphate Oral Solution, tell your
healthcare provider about all of your medical conditions, including if you:
have a drug dependence
have lung or breathing problems including chronic obstructive pulmonary disease (COPD), or sleep
apnea.
have had a head injury
have pain in your stomach-area (abdomen)
have a history of severe or persistent cough
have prostate problems
have problems with your urinary tract (urethral stricture) or difficulty urinating
have had surgery recently or plan to have surgery
drink alcohol
have kidney or liver problems
have thyroid problems including hypothyroidism
have Addison’s disease
have glaucoma (increased pressure in eyes)
have diabetes
have seizures
have heart problems or blood vessel (cardiovascular) problems including high blood pressure or
peripheral vascular insufficiency See

“Who should not take Promethazine Hydrochloride and
Codeine Phosphate Oral Solution?

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have blood disorders including low white blood cells
are pregnant or plan to become pregnant. It is not known if Promethazine Hydrochloride and Codeine
Phosphate Oral Solution will harm your unborn baby. You and your healthcare provider should
decide if you should take Promethazine Hydrochloride and Codeine Phosphate Oral Solution while
you are pregnant.
are breastfeeding or plan to breastfeed. Codeine Phosphate passes into your breast milk and may
harm your baby. It is not known if Promethazine Hydrochloride can pass into your breast milk. You
should not breastfeed during treatment with Promethazine Hydrochloride and Codeine Phosphate
Oral Solution.
Tell your healthcare provider about all the medicines you take, including prescription and over-
thecounter medicines, vitamins, and herbal supplements.
Taking Promethazine Hydrochloride and Codeine Phosphate Oral Solution with certain other medicines
can cause side effects or affect how well Promethazine Hydrochloride and Codeine Phosphate Oral
Solution or the other medicines work. Do not start or stop other medicines without talking to your
healthcare provider. Especially tell your healthcare provider if you:
take pain medicines such as narcotics
take cold or allergy medicines that contain antihistamines or cough suppressants
take medicines for mental illness (anti-psychotics, anti-anxiety)
drink alcohol
take medicines for depression, including monoamine oxidase inhibitors (MAOIs) or tricyclic
antidepressants (TCAs)
take medicines for stomach or intestinal problems
take ergot containing medicines
take medicines called alpha blockers
take medicines called beta blockers
take stimulants or uppers (amphetamines)
Ask your healthcare provider if you are not sure if you take one of these medicines.
How should I take Promethazine Hydrochloride and Codeine Phosphate Oral Solution?
Take Promethazine Hydrochloride and Codeine Phosphate Oral Solution exactly as your healthcare
provider tells you to take it.
Your healthcare provider will tell you how much Promethazine Hydrochloride and Codeine
Phosphate Oral Solution to take and when to take it. Do not change your dose without talking to your
healthcare provider.
Ask your pharmacist to give you a measuring device to help you measure the correct amount of
Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Do not use a household
teaspoon to measure your medicine. You may accidently take too much.
Do not take more than 30 mL of Promethazine Hydrochloride and Codeine Phosphate Oral Solution
in 24 hours.
If you take too much Promethazine Hydrochloride and Codeine Phosphate Oral Solution, call your
healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking Promethazine Hydrochloride and Codeine Phosphate Oral
Solution?

Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause you to be drowsy.
Avoid driving a car or operating machinery during the treatment with Promethazine Hydrochloride
and Codeine Phosphate Oral Solution. Also, watch your child closely when riding a bike.
Avoid drinking alcohol during the treatment with Promethazine Hydrochloride and Codeine
Phosphate Oral Solution. Drinking alcohol can increase your chances of having serious side
effects.
Avoid spending a long time in sunlight.\

What are the possible side effects of Promethazine Hydrochloride and Codeine Phosphate Oral
Solution?

Promethazine Hydrochloride and Codeine Phosphate Oral Solution may caus e s erious
side effects, including:
See “What is the most important information I should know about Promethazine Hydrochloride and
Codeine Phosphate Oral Solution?”
Breathing problems (respiratory depression) which can lead to death. Call your healthcare
provider or get emergency treatment right away if you have excessive sleepiness, shallow or slow
breathing, or confusion.
Physical dependence or abus e. Take Promethazine Hydrochloride and Codeine Phosphate Oral
Solution exactly as your healthcare provider tells you to take it. Stopping Promethazine
Hydrochloride and Codeine Phosphate Oral Solution suddenly could cause withdrawal symptoms.
Bowel problems including constipation or stomach pain.
Increased intracranial pressure.
Feeling dizzy, faint or light-headed, especially when you stand up (orthostatic hypotension) .
Light-headedness or fainting may happen when getting up too quickly from a sitting or lying
position.
Neuroleptic malignant syndrome (NMS) which can lead to death. Tell you healthcare provider
right away if you have any of the following symptoms of NMS:
high fever
stiff muscles
confusion
sweating
changes in pulse, heart rate, and blood pressure
The most common side effects of Promethazine Hydrochlorde and Codeine Phosphate Oral
Solution include:
sleepiness
confusion
dryness of mouth, nose, throat
nausea and vomiting
difficulty urinating
trouble breathing
high blood pressure
restlessness
fast heart beat

These are not all the possible side effects of Promethazine Hydrochloride and Codeine Phosphate Oral
Solution.
Call your doctor for medical advice about side effects.

How should I store Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

Store Promethazine Hydrochloride and Codeine Phosphate Oral Solution at room temperature
between 68°F to 77°F (20°C to 25°C).

Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a tightly closed,
childresistant container and out of the light.
Safely throw away medicine that is out of date or no longer needed.
Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution and all medicines
out of the reach of children.

General information about the safe and effective use of Promethazine Hydrochloride and Codeine
Phosphate Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not
use Promethazine Hydrochloride and Codeine Phosphate Oral Solution for a condition for which it was
not prescribed. Do not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to other
people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about Promethazine Hydrochloride
and Codeine Phosphate Oral Solution that is written for health professionals.

What are the ingredients in Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

Active ingredients: promethazine hydrochloride and codeine phosphate

Inactive ingredients: Artificial raspberry flavor, ascorbic acid, citric acid anhydrous, D&C Red #33,
dehydrated alcohol, edetate disodium, FDlue &C B#1, glycerin, liquid sugar, methylparaben, purified

water, saccharin sodium, sodium benzoate, sodium citrate dihydrate and sodium propionate.

 

 

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(Promethazine Hydrochloride and Codeine Phosphate Oral Solution)
What is the most important information I should know about Promethazine Hydrochloride and
Codeine Phosphate Oral Solution?
Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause children to stop
breathing (respiratory depression) and cause death.

Do not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to children
younger than 12 years of age, or to children younger than 18 years of age after tonsillectomy or
adenoidectomy surgery.
You should not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to
children between 12 to 18 years of age who have certain risk factors for breathing problems,
including:
recent surgery
obstructive sleep apnea
are obese
severe lung problems
other medical conditions that can cause difficulty breathing, such as neuromuscular problems
taking other medicines that cause breathing problems

You should not breastfeed during treatment with Promethazine Hydrochloride and Codeine
Phosphate Oral Solution because it may cause your child to stop breathing and cause death.
Severe drowsiness, breathing problems (respiratory depression), coma, and death can happen in
adults and children who take Promethazine Hydrochloride and Codeine Phosphate Oral Solution
with benzodiazepines, or other central nervous system depressants, including alcohol.
Avoid taking other medicines that can cause drowsiness or sleepiness, or drinking alcohol
during treatment with Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Ask
your healthcare provider for a list of these medicines if you are not sure.
Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause breathing problems
(respiratory depression) and drowsiness.

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Take Promethazine Hydrochloride and Codeine Phosphate Oral Solution exactly as prescribed
by your healthcare provider. If you take the wrong dose of Promethazine Hydrochloride and
Codeine Phosphate Oral Solution you could overdose and die. See the Medication Guide
section called “How should I take Promethazine Hydrochloride and Codeine Phosphate Oral
Solution?” for important information about how to take Promethazine Hydrochloride and Codeine
Phosphate Oral Solution correctly.
Avoid driving a car or operating machinery during treatment with Promethazine Hydrochloride
and Codeine Phosphate Oral Solution.

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Call your healthcare provider or get emergency medical help right away if anyone taking
Promethazine Hydrochloride and Codeine Phosphate Oral Solution, or your breastfeeding baby has
any of the symptoms below:
increased sleepiness
confusion
difficulty breathing
shallow breathing
limpness
your baby has difficulty breastfeeding

Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a safe place away from
children. Accidental use by a child is a medical emergency and can cause death. If a child
accidentally takes Promethazine Hydrochloride and Codeine Phosphate Oral Solution, get
emergency medical help right away.

What is Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

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Promethazine Hydrochloride and Codeine Phosphate Oral Solution is a prescription medicine used
to temporarily treat cough and upper respiratory symptoms, including a stuffy nose (nasal
congestion) that you can have with allergies or a common cold. Promethazine Hydrochloride and
Codeine Phosphate Oral Solution contains 2 medicines, promethazine and codeine. Promethazine is
an antihistamine. Codeine is a narcotic cough suppressant.
Promethazine Hydrochloride and Codeine Phosphate Oral Solution is a federal controlled
substance (C-V) becaus e it contains codeine that can be abus ed or lead to dependence. Keep
Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a safe place to prevent misuse
and abuse. Selling or giving away Promethazine Hydrochloride and Codeine Phosphate Oral
Solution may harm others, and is against the law. Tell your healthcare provider if you have ever
abused or been dependent on alcohol, prescription medicines or street drugs
Promethazine Hydrochloride and Codeine Phosphate Oral Solution is not for children under 12
years of age.
Who should not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution?
Do not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to children younger
than 12 years of age.
Do not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to children younger
than 18 years of any age after tonsillectomy or adenoidectomy surgery.
Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you are allergic
to any of the ingredients in Promethazine Hydrochloride and Codeine Phosphate Oral Solution. See
the end of this Medication Guide for a complete list of ingredients in Promethazine Hydrochloride
and Codeine Phosphate Oral Solution.
Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you have asthma.
Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you have high
blood pressure or narrowing of blood vessels to your legs or arms (peripheral vascular
insufficiency).
Do not take Promethazine Hydrochloride and Codeine Phosphate Oral Solution if you take a
medicine called a Monoamine Oxidase Inhibitor (MAOI).
Before you take Promethazine Hydrochloride and Codeine Phosphate Oral Solution, tell your
healthcare provider about all of your medical conditions, including if you:
have a drug dependence
have lung or breathing problems including chronic obstructive pulmonary disease (COPD), or sleep
apnea.
have had a head injury
have pain in your stomach-area (abdomen)
have a history of severe or persistent cough
have prostate problems
have problems with your urinary tract (urethral stricture) or difficulty urinating
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drink alcohol
have kidney or liver problems
have thyroid problems including hypothyroidism
have Addison’s disease
have glaucoma (increased pressure in eyes)
have diabetes
have seizures
have heart problems or blood vessel (cardiovascular) problems including high blood pressure or
peripheral vascular insufficiency See

“Who should not take Promethazine Hydrochloride and

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are pregnant or plan to become pregnant. It is not known if Promethazine Hydrochloride and Codeine
Phosphate Oral Solution will harm your unborn baby. You and your healthcare provider should
decide if you should take Promethazine Hydrochloride and Codeine Phosphate Oral Solution while
you are pregnant.
are breastfeeding or plan to breastfeed. Codeine Phosphate passes into your breast milk and may
harm your baby. It is not known if Promethazine Hydrochloride can pass into your breast milk. You
should not breastfeed during treatment with Promethazine Hydrochloride and Codeine Phosphate
Oral Solution.
Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements.
Taking Promethazine Hydrochloride and Codeine Phosphate Oral Solution with certain other medicines
can cause side effects or affect how well Promethazine Hydrochloride and Codeine Phosphate Oral
Solution or the other medicines work. Do not start or stop other medicines without talking to your
healthcare provider. Especially tell your healthcare provider if you:
take pain medicines such as narcotics
take cold or allergy medicines that contain antihistamines or cough suppressants
take medicines for mental illness (anti-psychotics, anti-anxiety)
drink alcohol
take medicines for depression, including monoamine oxidase inhibitors (MAOIs) or tricyclic
antidepressants (TCAs)
take medicines for stomach or intestinal problems
take ergot containing medicines
take medicines called alpha blockers
take medicines called beta blockers
take stimulants or uppers (amphetamines)
Ask your healthcare provider if you are not sure if you take one of these medicines.
How should I take Promethazine Hydrochloride and Codeine Phosphate Oral Solution?
Take Promethazine Hydrochloride and Codeine Phosphate Oral Solution exactly as your healthcare
provider tells you to take it.
Your healthcare provider will tell you how much Promethazine Hydrochloride and Codeine
Phosphate Oral Solution to take and when to take it. Do not change your dose without talking to your
healthcare provider.
Ask your pharmacist to give you a measuring device to help you measure the correct amount of
Promethazine Hydrochloride and Codeine Phosphate Oral Solution. Do not use a household
teaspoon to measure your medicine. You may accidently take too much.
Do not take more than 30 mL of Promethazine Hydrochloride and Codeine Phosphate Oral Solution
in 24 hours.
If you take too much Promethazine Hydrochloride and Codeine Phosphate Oral Solution, call your
healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking Promethazine Hydrochloride and Codeine Phosphate Oral
Solution?

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Promethazine Hydrochloride and Codeine Phosphate Oral Solution can cause you to be drowsy.
Avoid driving a car or operating machinery during the treatment with Promethazine Hydrochloride
and Codeine Phosphate Oral Solution. Also, watch your child closely when riding a bike.
Avoid drinking alcohol during the treatment with Promethazine Hydrochloride and Codeine
Phosphate Oral Solution. Drinking alcohol can increase your chances of having serious side
effects.
Avoid spending a long time in sunlight.\

What are the possible side effects of Promethazine Hydrochloride and Codeine Phosphate Oral
Solution?

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Promethazine Hydrochloride and Codeine Phosphate Oral Solution may caus e s erious
side effects, including:
See “What is the most important information I should know about Promethazine Hydrochloride and
Codeine Phosphate Oral Solution?”
Breathing problems (respiratory depression) which can lead to death. Call your healthcare
provider or get emergency treatment right away if you have excessive sleepiness, shallow or slow
breathing, or confusion.
Physical dependence or abus e. Take Promethazine Hydrochloride and Codeine Phosphate Oral
Solution exactly as your healthcare provider tells you to take it. Stopping Promethazine
Hydrochloride and Codeine Phosphate Oral Solution suddenly could cause withdrawal symptoms.
Bowel problems including constipation or stomach pain.
Increased intracranial pressure.
Feeling dizzy, faint or light-headed, especially when you stand up (orthostatic hypotension) .
Light-headedness or fainting may happen when getting up too quickly from a sitting or lying
position.
Neuroleptic malignant syndrome (NMS) which can lead to death. Tell you healthcare provider
right away if you have any of the following symptoms of NMS:
high fever
stiff muscles
confusion
sweating
changes in pulse, heart rate, and blood pressure
The most common side effects of Promethazine Hydrochlorde and Codeine Phosphate Oral
Solution include:
sleepiness
confusion
dryness of mouth, nose, throat
nausea and vomiting
difficulty urinating
trouble breathing
high blood pressure
restlessness
fast heart beat

These are not all the possible side effects of Promethazine Hydrochloride and Codeine Phosphate Oral
Solution.
Call your doctor for medical advice about side effects.

How should I store Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

Store Promethazine Hydrochloride and Codeine Phosphate Oral Solution at room temperature
between 68°F to 77°F (20°C to 25°C).

Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution in a tightly closed, childresistant container and out of the light.
Safely throw away medicine that is out of date or no longer needed.
Keep Promethazine Hydrochloride and Codeine Phosphate Oral Solution and all medicines
out of the reach of children.

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General information about the safe and effective use of Promethazine Hydrochloride and Codeine
Phosphate Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not
use Promethazine Hydrochloride and Codeine Phosphate Oral Solution for a condition for which it was
not prescribed. Do not give Promethazine Hydrochloride and Codeine Phosphate Oral Solution to other
people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about Promethazine Hydrochloride
and Codeine Phosphate Oral Solution that is written for health professionals.

What are the ingredients in Promethazine Hydrochloride and Codeine Phosphate Oral Solution?

Active ingredients: promethazine hydrochloride and codeine phosphate

Inactive ingredients: Artificial raspberry flavor, ascorbic acid, citric acid anhydrous, D&C Red #33,
dehydrated alcohol, edetate disodium, FD&C Blue #1, glycerin, liquid sugar, methylparaben, purified
water, saccharin sodium, sodium benzoate, sodium citrate dihydrate and sodium propionate

 

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