Children’s Cold & Cough Drug Facts

SPL v2

SPL

SPL Set ID cead7f84-382c-450c-9fcd-91cd3893db75

Route

ORAL

Published

Effective Date 2023-05-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Brompheniramine (2 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH FINAL Active Since 2023-05-08

Description

Brompheniramine maleate, 2 mg Dextromethorphan HBr, 10 mg Phenylephrine HCl , 5 mg

Purpose

Antihistamine Cough suppressant Nasal decongestant

Medication Information

Purpose

Antihistamine Cough suppressant Nasal decongestant

Description

Brompheniramine maleate, 2 mg Dextromethorphan HBr, 10 mg Phenylephrine HCl , 5 mg

Uses

▪
temporarily relieves:
▪
Nasal congestion
- ▪
  runny nose
- ▪
  cough
- ▪
  sneezing
- ▪
  itchy, watery eyes due to hay fever
- ▪
  itching of the nose or throat
▪
temporarily restores freer breathing through the nose

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Directions

▪
do not take more than 6 doses in any 24-hour period
▪
measure only with dosage 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

Do Not Use

▪
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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information

▪
each 10 ml contains: sodium 6 mg
▪
store at room temperature.

Inactive Ingredients

anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, artificial flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions Or Comments?

1-866-467-2748

Principal Display Panel

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

NDC 55319-645-04

Children's

Cold

& Cough

Brompheniramine maleate (Antihistamine)

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves Nasal Symptoms

•
Stuffy Nose
•
Runny Nose
•
Sneezing

Plus Other Symptoms

•
Itchy, Watery Eyes
•
Cough

For Ages 6 Years and Over

Grape Flavor

Naturally and Artificially Flavored

4 FL OZ (118 ml)

Distributed by:

*This product is not distributed by Foundation Consumer Brands, LLC, the distributor of Children’s Dimetapp® Cold & Cough*.

When Using This Product

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

Stop Use and Ask A Doctor If

•
nervousness, dizziness, or sleeplessness occurs
•
symptoms do not get better within 7 days or are 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.

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

Active Ingredients (in Each 10 Ml)

Brompheniramine maleate, 2 mg

Dextromethorphan HBr, 10 mg

Phenylephrine HCl , 5 mg

Ask A Doctor Before Use If You Have

▪
heart disease
▪
high blood pressure
▪
thyroid disease
▪
diabetes
▪
trouble urinating due to an enlarged prostate gland
▪
glaucoma
▪
cough that occurs with too much phlegm (mucus)
▪
a breathing problem or persistent 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

▪
taking any other oral nasal decongestant or stimulant
▪
taking sedatives or tranquilizers

Structured Label Content

Uses

▪
temporarily relieves:
▪
Nasal congestion
- ▪
  runny nose
- ▪
  cough
- ▪
  sneezing
- ▪
  itchy, watery eyes due to hay fever
- ▪
  itching of the nose or throat
▪
temporarily restores freer breathing through the nose

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Directions

▪
do not take more than 6 doses in any 24-hour period
▪
measure only with dosage 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

Do Not Use (Do not use)

▪
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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information (Other information)

▪
each 10 ml contains: sodium 6 mg
▪
store at room temperature.

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, artificial flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

NDC 55319-645-04

Children's

Cold

& Cough

Brompheniramine maleate (Antihistamine)

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves Nasal Symptoms

•
Stuffy Nose
•
Runny Nose
•
Sneezing

Plus Other Symptoms

•
Itchy, Watery Eyes
•
Cough

For Ages 6 Years and Over

Grape Flavor

Naturally and Artificially Flavored

4 FL OZ (118 ml)

Distributed by:

*This product is not distributed by Foundation Consumer Brands, LLC, the distributor of Children’s Dimetapp® Cold & Cough*.

When Using This Product (When using this product)

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

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

•
nervousness, dizziness, or sleeplessness occurs
•
symptoms do not get better within 7 days or are 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.)

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

Active Ingredients (in Each 10 Ml) (Active ingredients (in each 10 ml))

Brompheniramine maleate, 2 mg

Dextromethorphan HBr, 10 mg

Phenylephrine HCl , 5 mg

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

▪
heart disease
▪
high blood pressure
▪
thyroid disease
▪
diabetes
▪
trouble urinating due to an enlarged prostate gland
▪
glaucoma
▪
cough that occurs with too much phlegm (mucus)
▪
a breathing problem or persistent 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)

▪
taking any other oral nasal decongestant or stimulant
▪
taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "BROMPHENIRAMINE", "unii": "H57G17P2FN", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYL GALLATE", "unii": "8D4SNN7V92", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "▪ temporarily relieves: ▪ Nasal congestion ▪ runny nose ▪ cough ▪ sneezing ▪ itchy, watery eyes due to hay fever ▪ itching of the nose or throat ▪ temporarily restores freer breathing through the nose", "Purposes": "Antihistamine Cough suppressant Nasal decongestant", "Directions": "▪ do not take more than 6 doses in any 24-hour period ▪ measure only with dosage 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", "Do not use": "▪ 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "Other information": "▪ each 10 ml contains: sodium 6 mg ▪ store at room temperature.", "Inactive ingredients": "anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, artificial flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose", "Questions or comments?": "1-866-467-2748", "PRINCIPAL DISPLAY PANEL": "Compare to the active ingredients in Children’s Dimetapp® Cold & Cough* NDC 55319-645-04 Children's Cold & Cough Brompheniramine maleate (Antihistamine) Dextromethorphan HBr (Cough Suppressant) Phenylephrine HCl (Nasal Decongestant) Relieves Nasal Symptoms • Stuffy Nose • Runny Nose • Sneezing Plus Other Symptoms • Itchy, Watery Eyes • Cough For Ages 6 Years and Over Grape Flavor Naturally and Artificially Flavored 4 FL OZ (118 ml) Distributed by: *This product is not distributed by Foundation Consumer Brands, LLC, the distributor of Children’s Dimetapp® Cold & Cough*.", "When using this product": "▪ do not use more than directed ▪ may cause marked drowsiness ▪ avoid alcoholic beverages ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ be careful when driving a motor vehicle or operating machinery ▪ excitability may occur, especially in children", "Stop use and ask a doctor if": "• nervousness, dizziness, or sleeplessness occurs • symptoms do not get better within 7 days or are 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.": "In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.", "Active ingredients (in each 10 ml)": "Brompheniramine maleate, 2 mg Dextromethorphan HBr, 10 mg Phenylephrine HCl , 5 mg", "Ask a doctor before use if you have": "▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ trouble urinating due to an enlarged prostate gland ▪ glaucoma ▪ cough that occurs with too much phlegm (mucus) ▪ a breathing problem or persistent 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": "▪ taking any other oral nasal decongestant or stimulant ▪ taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:13.407921 · Updated: 2026-03-14T23:01:19.203951