CHILDRENS COUGH AND COLD- chlorpheniramine maleate, dextrometrorphan hbr liquid

Childrens Cough and Cold by

Drug Labeling and Warnings

Childrens Cough and Cold by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR SERVICES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredients (in each 10 mL)

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 15 mg

Purposes

Antihistamine

Cough suppressant

Uses

• ▪ temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• ▪ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • ▪ runny nose
  • ▪ sneezing
  • ▪ itchy, watery eyes
  • ▪ itching of the nose or throat

WARNINGS

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.

Ask a doctor before use if you have

• ▪ trouble urinating due to an enlarged prostate gland
• ▪ glaucoma
• ▪ a cough that occurs with too much phlegm (mucus)
• ▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis 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
• ▪ marked drowsiness may occur
• ▪ 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

Stop use and ask a doctor if

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 right away at 1-800-222-1222.

Directions

• ▪ measure only with dosing cup provided
• ▪ keep dosing cup with product
• ▪ mL = milliliter
• ▪ do not take more than 4 doses in any 24-hour period

age	dose
Children under 6 years	do not use
children 6 to under 12 years	10 mL every 6 hours
adults and children 12 years and older	20 mL every 6 hours

Other information

• ▪ each 10 mL contains: sodium 7 mg
• ▪ store at room temperature. Do not refrigerate.

Inactive ingredients

Anhydrous citric acid, FD&C red no. 40, Glycerin, lactic acid, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

QUESTIONS OR COMMENTS?

1-866-467-2748

Prinipal Display of Packaging

Compare to the active ingredients in Children’s Robitussin® Cough & Cold Long–Acting*

NDC: 55319-754-04

CHILDREN’S

COUGH & COLD

Chlorpheniramine Maleate USP 2 mg (Antihistamine)

Dextromethorphan HBr, USP 15 mg (Cough Suppressant)

Long-Acting

Relieves:

• Cough up to 8 hours
• Runny nose
• No Added alcohol
•   For Ages 6 & Over

Fruit Punch Flavor

Naturally and Artificially Flavored

4 FL OZ (118 mL)

IMPORTANT: Keep this carton for future reference on full labeling

Distributed by:

INGREDIENTS AND APPEARANCE

CHILDRENS COUGH AND COLD 
chlorpheniramine maleate, dextrometrorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-754
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
chlorpheniramine maleate (UNII: V1Q0O9OJ9Z) (chlorpheniramine - UNII:3U6IO1965U)	chlorpheniramine maleate	2 mg  in 10 mL
dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS)	dextromethorphan hydrobromide	15 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	FRUIT PUNCH	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-754-04	1 in 1 CARTON	05/08/2023
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 final	part341	05/08/2023

Labeler - FAMILY DOLLAR SERVICES INC (024472631)