CHILDRENS COUGH AND COLD- chlorpheniramine maleate, dextrometrorphan hbr liquid 
FAMILY DOLLAR SERVICES INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Family Dollar Children’s Cough & Cold

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
agedose

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:

Family Dollar childrens Cough & Cold  4 FL  OZ  Fruit Punch Flavor
CHILDRENS COUGH AND COLD 
chlorpheniramine maleate, dextrometrorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-754
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
chlorpheniramine maleate (UNII: V1Q0O9OJ9Z) (chlorpheniramine - UNII:3U6IO1965U) chlorpheniramine maleate2 mg  in 10 mL
dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS) dextromethorphan hydrobromide15 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScore    
ShapeSize
FlavorFRUIT PUNCHImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-754-041 in 1 CARTON05/08/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/08/2023
Labeler - FAMILY DOLLAR SERVICES INC (024472631)

Revised: 9/2023
Document Id: 30a802eb-6250-46a1-8906-ee0d364a3c70
Set id: 4c06b5cf-036d-4bbd-b055-a07bf2015beb
Version: 2
Effective Time: 20230916
 
FAMILY DOLLAR SERVICES INC