Cvs Children’s Cold & Cough & Children’s Nighttime Cold & Cough Value Pack Drug Facts

Cvs Children’s Cold & Cough & Children’s Nighttime Cold & Cough Value Pack Drug Facts
SPL v2
SPL
SPL Set ID 4d94968b-ada3-4344-8563-cba7fc491d74
Route
ORAL
Published
Effective Date 2025-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Brompheniramine (2 mg) Dextromethorphan (10 mg) Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propyl Gallate Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-03

Description

Brompheniramine maleate, 2 mg Dextromethorphan HBr, 10 mg

Purpose

Antihistamine Cough suppressant


Medication Information

Purpose

Antihistamine Cough suppressant

Description

Brompheniramine maleate, 2 mg Dextromethorphan HBr, 10 mg

Uses

Cold & Cough

  • temporarily relieves
    • runny nose
    • cough
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever (or other upper respiratory allergies)
    • temporarily alleviates the intensity of coughing

Nighttime Cold & Cough

  • temporarily relieves
    • runny nose
    • cough
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever (or other upper respiratory allergies)
    • relieves the impulse to cough to help you sleep.
Directions

Cold & Cough

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided.
  • Keep dosage cup with product
  • mL= milliliter

age

dose

Adults and children 12 years and over

20 mL every 4 hours

children 6 to under 12 years

10 mL every 4 hours

children under 6 years

do not use



Nighttime cold & cough

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided.
  • Keep dosage cup with product
  • mL= milliliter

age

dose

 Adults and children 12 years and over

 20 mL every 4 hours

 children 6 to under 12 years

10 mL every 4 hours

 children under 6 years

do not use

Purposes For

Antihistamine

Cough suppressant

Product Label
Other Information

Cold & cough

  • each 10 mL contains:sodium 6 mg
  • store at room temperature.

Nighttime cold & cough

  • each 10 mL contains:sodium 6 mg
  • store at room temperature.
Warnings Do Not Use

Cold & Cough

  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Nighttime Cold & Cough

  • to sedate a child or to make a child sleepy
  • With any other product containing diphenhydramine, even one used on skin
Inactive Ingredients

Inactive ingredients for Cold & Cough 

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Inactive ingredients for Nighttime 

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Children’s Nighttime

Diphenhydramine HCL12.5 mg

Questions Or Comments?

1-866-467-2748

Principal Display Panel

Compare to the active ingredients in Children's Dimetapp® Cold & Cough*

Children's

Cold & Cough

Brompheniramine Maleate (Antihistamine),

Dextromethorphan HBr (Cough Suppressant)

Relieves + comforts

  • Runny nose
  • Itchy, watery eyes
  • Sneezing
  • Cough

For Ages 6 Years and over

No Added Alcohol

Grape Flavor

Naturally and Artificially Flavored

Compare to the active ingredients in Children's Dimetapp® Nighttime Cold & Congestion**

Children's Nighttime

Cold & Cough

Diphenhydramine HCI (Antihistamine / Cough Suppressant)

Relieves + comforts

  • Runny nose
  • Itchy, watery eyes
  • Sneezing
  • Cough

For Ages 6 Years and over

No Added Alcohol

Grape Flavor

Naturally and Artificially Flavored

2-4 FL OZ (118 mL) BOTTLES/TOTAL 8 FL OZ (236 mL)

Do not take both products at the same time. Always wait at least 4 hours before taking another dose of the product.

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

IMPORTANT:KEEP THIS CARTON FOR FUTURE REFERENCE FOR FULL LABELING

*This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children's Dimetapp® Cold & Cough.

**This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children's Dimetapp® Nighttime Cold & Cough.

Distributed by:

When Using This Product

Cold & Cough

  • do not use more than directed.
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Nighttime cold & cough

  • do not use more than directed.
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Children’s Cold & Cough

Brompheniramine maleate, 2 mg

Dextromethorphan HBr, 10 mg

Stop Use and Ask A Doctor If

Cold & Cough

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

Nighttime cold & cough

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

Ask a health professional before use

Keep Out of Reach of Children.

Cold & Cough

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Nighttime Cold & Cough

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Ask A Doctor Before Use if You Have

Cold & Cough

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Nighttime Cold & Cough

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Ask A Doctor Or Pharmacist Before Use If You Are

Cold & Cough

taking sedatives or tranquilizers

Nighttime Cold & Cough

taking sedatives or tranquilizers


Structured Label Content

Uses

Cold & Cough

  • temporarily relieves
    • runny nose
    • cough
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever (or other upper respiratory allergies)
    • temporarily alleviates the intensity of coughing

Nighttime Cold & Cough

  • temporarily relieves
    • runny nose
    • cough
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever (or other upper respiratory allergies)
    • relieves the impulse to cough to help you sleep.
Directions

Cold & Cough

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided.
  • Keep dosage cup with product
  • mL= milliliter

age

dose

Adults and children 12 years and over

20 mL every 4 hours

children 6 to under 12 years

10 mL every 4 hours

children under 6 years

do not use



Nighttime cold & cough

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided.
  • Keep dosage cup with product
  • mL= milliliter

age

dose

 Adults and children 12 years and over

 20 mL every 4 hours

 children 6 to under 12 years

10 mL every 4 hours

 children under 6 years

do not use

Purposes For (Purposes for)

Antihistamine

Cough suppressant

Product Label
Other Information (Other information)

Cold & cough

  • each 10 mL contains:sodium 6 mg
  • store at room temperature.

Nighttime cold & cough

  • each 10 mL contains:sodium 6 mg
  • store at room temperature.
Warnings Do Not Use (Warnings Do not use)

Cold & Cough

  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Nighttime Cold & Cough

  • to sedate a child or to make a child sleepy
  • With any other product containing diphenhydramine, even one used on skin
Inactive Ingredients (Inactive ingredients)

Inactive ingredients for Cold & Cough 

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Inactive ingredients for Nighttime 

citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Children’s Nighttime

Diphenhydramine HCL12.5 mg

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

Compare to the active ingredients in Children's Dimetapp® Cold & Cough*

Children's

Cold & Cough

Brompheniramine Maleate (Antihistamine),

Dextromethorphan HBr (Cough Suppressant)

Relieves + comforts

  • Runny nose
  • Itchy, watery eyes
  • Sneezing
  • Cough

For Ages 6 Years and over

No Added Alcohol

Grape Flavor

Naturally and Artificially Flavored

Compare to the active ingredients in Children's Dimetapp® Nighttime Cold & Congestion**

Children's Nighttime

Cold & Cough

Diphenhydramine HCI (Antihistamine / Cough Suppressant)

Relieves + comforts

  • Runny nose
  • Itchy, watery eyes
  • Sneezing
  • Cough

For Ages 6 Years and over

No Added Alcohol

Grape Flavor

Naturally and Artificially Flavored

2-4 FL OZ (118 mL) BOTTLES/TOTAL 8 FL OZ (236 mL)

Do not take both products at the same time. Always wait at least 4 hours before taking another dose of the product.

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

IMPORTANT:KEEP THIS CARTON FOR FUTURE REFERENCE FOR FULL LABELING

*This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children's Dimetapp® Cold & Cough.

**This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children's Dimetapp® Nighttime Cold & Cough.

Distributed by:

When Using This Product (When using this product)

Cold & Cough

  • do not use more than directed.
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Nighttime cold & cough

  • do not use more than directed.
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Children’s Cold & Cough

Brompheniramine maleate, 2 mg

Dextromethorphan HBr, 10 mg

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Cold & Cough

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

Nighttime cold & cough

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

Ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

Cold & Cough

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Nighttime Cold & Cough

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Ask A Doctor Before Use if You Have (Ask a doctor before use if you have)

Cold & Cough

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Nighttime Cold & Cough

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

Cold & Cough

taking sedatives or tranquilizers

Nighttime Cold & Cough

taking sedatives or tranquilizers


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Raw Label Data

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