CHILDRENS DIMETAPP COLD AND COUGH- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl 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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Children’s Cold & Cough Drug Facts

Active ingredients (in each 10 ml)

Brompheniramine maleate, 2 mg

Dextromethorphan HBr, 10 mg

Phenylephrine HCl , 5 mg

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Uses

temporarily relieves:
Nasal congestion
runny nose
cough
sneezing
itchy, watery eyes due to hay fever
itching of the nose or throat
temporarily restores freer breathing through the nose

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

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
glaucoma
cough that occurs with too much phlegm (mucus)
a breathing problem or persistent or chronic cough that lasts such as 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

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

nervousness, dizziness, or sleeplessness occurs
symptoms do not get better within 7 days or are 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

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
agedose

adults and children 12 years and 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 6 mg
store at room temperature.

Inactive ingredients

anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, artificial flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

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

NDC 55319-645-04

Children's

Cold
& Cough

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

For Ages 6 Years and Over

Grape Flavor

Naturally and Artificially Flavored

4 FL OZ (118 ml)

Distributed by:

*This product is not distributed by Foundation Consumer Brands, LLC, the distributor of Children’s Dimetapp® Cold & Cough*.

 Children's Cold & Cough 4 FL OZ 118 mL
CHILDRENS DIMETAPP COLD AND COUGH 
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-645
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPURPLE (purple liquid) Score    
ShapeSize
FlavorGRAPE (grape flavor and odor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-645-041 in 1 CARTON05/08/2023
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
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: 5ce66097-4718-4cb5-872a-a7d4816773b8
Set id: cead7f84-382c-450c-9fcd-91cd3893db75
Version: 2
Effective Time: 20230916
 
FAMILY DOLLAR SERVICES INC