OTC Medication Information: CHILDRENS DIMETAPP COLD AND COUGH

CHILDRENS DIMETAPP COLD AND COUGH- brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride 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.

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

age	dose
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*.

CHILDRENS DIMETAPP COLD AND COUGH brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-645 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE 2 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL PROPYL GALLATE WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE

Product Characteristics Color PURPLE (purple liquid) Score Shape Size Flavor GRAPE (grape flavor and odor) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55319-645-04 1 BOTTLE in 1 CARTON contains a BOTTLE 1 118 mL in 1 BOTTLE This package is contained within the CARTON (55319-645-04)

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)

Revised: 09/2023 FAMILY DOLLAR SERVICES INC