Retail Business Services, Llc. Children’s Cold & Cough Drug Facts

Retail Business Services, Llc. Children’s Cold & Cough Drug Facts
SPL v2
SPL
SPL Set ID 382f7d51-ceb8-4bdf-9bd5-440b50c65cd3
Route
ORAL
Published
Effective Date 2025-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Brompheniramine (2 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sorbitol Solution

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-16
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
  • •
    temporarily relieves:
    • •
      cough
    • •
      runny nose
    • •
      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
Purposes

Antihistamine

Cough suppressant

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 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
  • •
    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.
  • •
    to make a child sleepy
Other Information
  • •
    each 10 mL contains: sodium 4 mg
  • •
    store at 20°-25°C (68°-77°F)
Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Questions Or Comments?

1-800-719-9260

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

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).

Active Ingredients (in Each 10 Ml)

Brompheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Ask A Doctor Before Use If You Have
  • •
    trouble urinating due to an enlarged prostate gland
  • •
    glaucoma
  • •
    cough that occurs with too much phlegm (mucus)
  • •
    a breathing problem such as emphysema or chronic bronchitis
  • •
    cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
Package/label Principal Display Panel

CAREone®

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

Safe and Effective Relief without Phenylephrine

For Ages 6 and Older

Children’s

COLD & COUGH

Antihistamine – Brompheniramine Maleate, 2 mg

Cough Suppressant – Dextromethorphan HBr, 10 mg

FOR RELIEF OF:

• Runny Nose

• Itchy, Watery Eyes

• Coughing & Sneezing

• Alcohol Free

Gluten Free

Grape Flavor

4 FL OZ (118 mL)

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

Structured Label Content

Uses
  • •
    temporarily relieves:
    • •
      cough
    • •
      runny nose
    • •
      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
Purposes

Antihistamine

Cough suppressant

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 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)
  • •
    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.
  • •
    to make a child sleepy
Other Information (Other information)
  • •
    each 10 mL contains: sodium 4 mg
  • •
    store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Questions Or Comments? (Questions or comments?)

1-800-719-9260

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)

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 (1-800-222-1222).

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

Brompheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • •
    trouble urinating due to an enlarged prostate gland
  • •
    glaucoma
  • •
    cough that occurs with too much phlegm (mucus)
  • •
    a breathing problem such as emphysema or chronic bronchitis
  • •
    cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
Package/label Principal Display Panel (Package/Label Principal Display Panel)

CAREone®

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

Safe and Effective Relief without Phenylephrine

For Ages 6 and Older

Children’s

COLD & COUGH

Antihistamine – Brompheniramine Maleate, 2 mg

Cough Suppressant – Dextromethorphan HBr, 10 mg

FOR RELIEF OF:

• Runny Nose

• Itchy, Watery Eyes

• Coughing & Sneezing

• Alcohol Free

Gluten Free

Grape Flavor

4 FL OZ (118 mL)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:32.498395 · Updated: 2026-03-14T23:09:21.323328