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

Childrens Cold and Cough by

Drug Labeling and Warnings

Childrens Cold and Cough by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH 110, LLC. DBA LEADER, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGRADIENTS (in each 10 mL)

Brompheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 10  mg

Phenylephrine HCl, USP 5 mg

PURPOSES

Antihistamine

Cough Suppressant

Nasal decongestant

USES

• temporarily relieves cough due to minor bronchial irritation as may occur with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies

• temporarily relieves these symptoms due to hay fever (allergic rhinitis):

• sneezing
• Itching of the nose or throat
• runny nose
• itchy, watery eyes

• 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, or  psychiatric, 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
• glaucoma
• diabetes
• thyroid disease
• high blood pressure
• difficulty in urination due to an enlarged prostate gland
• 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 sedative or tranquilizers

WHEN USING THIS PRODUCT

• do not take more than directed
• may cause drowsiness
• alcohol, sedatives, and tranquillizers may increase drowsiness
• avoid alcoholic beverages
• 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 occur
• symptoms do not improve within 7 days or are accompanied by fever
• 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 (1-800-222-1222) right away.

DIRECTIONS

• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided
• do not exceed recommended dosage
• mL = milliliter

• Age: Dose
• adults & children 12 years & 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 10 mg
• store at 20-25ºC (68-77ºF)
• measuring cup provided

INACTIVE INGREDIENTS

anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C Red #40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

QUESTIONS OR COMMENTS?

call (609) 860-2600 Mon - Fri 8:00 am to 4:30 pm est

PRINCIPAL DISPLAY PANEL

LEADER

NDC: 70000-0631-1

Children's Cold & Cough Liquid

Brompheniramine Maleate

Dextromethorphan Hydrobromide

Phenylephrine Hydrochloride

Antihistamine 

Cough Suppressant

Nasal Decongestant
Grape 

Flavor

Relieves:

Stuffy Nose,

Runny Nose,

Sneezing,

Cough

Alcohol-Free

COMPARE TO CHILDREN'S DIMETAPP®

COLD & COUGH

active ingredients*

4 FL OZ (118 mL)

       

  

 

 

    

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0631
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	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)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYL GALLATE (UNII: 8D4SNN7V92)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0631-1	1 in 1 CARTON	03/30/2023
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	03/30/2023

Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(70000-0631)