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

CHILDRENS DIMETAPP COLD AND COUGH by

Drug Labeling and Warnings

CHILDRENS DIMETAPP COLD AND COUGH by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR SERVICES INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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*.

INGREDIENTS AND APPEARANCE

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

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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PURPLE (purple liquid)	Score
Shape		Size
Flavor	GRAPE (grape flavor and odor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-645-04	1 in 1 CARTON	05/08/2023
1		118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

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)