Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID ff712454-32df-4839-98d1-a6844a1bba96

Route

ORAL

Published

Effective Date 2023-01-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

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 Water Sodium Benzoate Trisodium Citrate Dihydrate Sorbitol Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Completed Since 2015-10-31 Until 2025-10-31

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 cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itchy, watery eyes
- 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 a 24-hour period
measure only with dosing cup provided. Do not use any other dosing device
keep dosing cup with product
mL = milliliter

age	dose
adults and children 12 years and over	20 mL every 4 hours
children 6 to 11 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.

Package Label

FAMILY WELLNESS Children's Cold & Cough Relief

Other Information

each 10 mL contains: sodium 5 mg
store between 20-25ºC (68-77ºF). Do not refrigerate

Inactive Ingredients

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

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S DIMETAPP® COLD & COUGH*

Children's

Cold & Cough Relief

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
Itching of the nose or throat

Alcohol free

GRAPE FLAVOR

FL OZ (mL)

Dosing Cup Included

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

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY,

CHESAPEAKE, VA 23320

When Using This Product

do not use more than directed
marked drowsiness may occur
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 improve within 7 days or are accompanied by fever
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.

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

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
glaucoma
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
a breathing problem or persistent or chronic cough that lasts such 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 cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itchy, watery eyes
- 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 a 24-hour period
measure only with dosing cup provided. Do not use any other dosing device
keep dosing cup with product
mL = milliliter

age	dose
adults and children 12 years and over	20 mL every 4 hours
children 6 to 11 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.

Package Label

FAMILY WELLNESS Children's Cold & Cough Relief

Other Information (Other information)

each 10 mL contains: sodium 5 mg
store between 20-25ºC (68-77ºF). Do not refrigerate

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S DIMETAPP® COLD & COUGH*

Children's

Cold & Cough Relief

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
Itching of the nose or throat

Alcohol free

GRAPE FLAVOR

FL OZ (mL)

Dosing Cup Included

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

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY,

CHESAPEAKE, VA 23320

When Using This Product (When using this product)

do not use more than directed
marked drowsiness may occur
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 improve within 7 days or are accompanied by fever
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.)

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

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
glaucoma
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
a breathing problem or persistent or chronic cough that lasts such 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": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "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 cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes 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 a 24-hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours children 6 to 11 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.", "Package Label": "FAMILY WELLNESS Children's Cold & Cough Relief", "Other information": "each 10 mL contains : sodium 5 mg store between 20-25ºC (68-77ºF). Do not refrigerate", "Inactive ingredients": "citric acid, FD&C blue #1, FD&C red 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST ", "Principal Display Panel": "COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S DIMETAPP® COLD & COUGH* Children's Cold & Cough Relief 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 Itching of the nose or throat Alcohol free GRAPE FLAVOR FL OZ (mL) Dosing Cup Included *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Children's Dimetapp® Cold & Cough. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY: MIDWOOD BRANDS, LLC 500 VOLVO PARKWAY, CHESAPEAKE, VA 23320", "When using this product": "do not use more than directed marked drowsiness may occur 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 improve within 7 days or are accompanied by fever 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.": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "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 glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:30.029244 · Updated: 2026-03-14T23:00:57.322924