CAREONE CHILDRENS COLD COUGH- brompheniramine maleate, dextromethorphan hydrobromide solution

CAREONE CHILDRENS COLD COUGH by

Drug Labeling and Warnings

CAREONE CHILDRENS COLD COUGH by is a Otc medication manufactured, distributed, or labeled by Retail Business Services, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 10 mL)

Brompheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Purposes

Antihistamine

Cough suppressant

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

Warnings

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

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

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).

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

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

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)

INGREDIENTS AND APPEARANCE

CAREONE CHILDRENS COLD COUGH 
brompheniramine maleate, dextromethorphan hydrobromide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-199
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL SOLUTION (UNII: 8KW3E207O2)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72476-199-26	1 in 1 CARTON	07/16/2025
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/16/2025

Labeler - Retail Business Services, LLC (967989935)