GILTUSS CHILDRENS COUGH AND CHEST CONGESTION- dextromethorphan hydrobromide, guaifenesin solution

Giltuss Childrens Cough and Chest Congestion by

Drug Labeling and Warnings

Giltuss Childrens Cough and Chest Congestion by is a Otc medication manufactured, distributed, or labeled by Dextrum Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Indication and usage section

Indication and usage section

Not take more than 6 doses in any 24 hours period.

Use enclosed dosing cup. keep dosage cup for use with this product

ML=Milliliters

Children under 4 years, consult a doctor

Children 4 to under 6 years, 2.5 ml every 4 hours

Children 6 to under 12 years, 5 ml every 4 hours

Children 12 years and over, 10 ml every 4 hours

Active ingredient section

Active ingredient section

(in each 5 ml)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Active ingredient section

Inactive ingredient

Citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water and sucralose.

Purpose section

Purpose section

Cough suppressant

Expectorant

Warnings

Warnings

Do not use if you child is now taking a prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression, psychiatric or emotional condition, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child prescription drug contains an MAOI ask a doctor or pharmacist before taking this product.

Keep out of reach of childrens section

Keep out of reach of childrens section

In case of a overdose, get medical help or contacta Poison Control Center right away

Question section

Question section

Call 1-787-848-9114 Monday-Friday 9AM-5PM EST.

Call your doctor for medical advice in the event of side effects.

Ask a doctor section

Ask a doctor section

Ask a doctor before use if the child has

cough that occurs with much phlegm(mucus)

a breathing problem or persistent or chronic cough that lasts such as occurs with asthma.

stop use section

stop use section

Stop use ans ask doctor of pharmacist if the child has symptoms do not get better within 7 days or are accompanied by fever, cough comes back or is accompanied by fever rash or persistent headache.

Dosage and Administratiion section

Dosage and Administratiion section

Not take more than 6 doses in any 24 hours period.

Use enclosed dosing cup. keep dosage cup for use with this product

ML=Milliliters

Children under 4 years, consult a doctor

Children 4 to under 6 years, 2.5 ml every 4 hours

Children 6 to under 12 years, 5 ml every 4 hours

Children 12 years and over, 10 ml every 4 hours

Package Label. Principal Display Panel

Package Label. Principal Display Panel

G Children, ninos 4-12

Children's

Giltuss

Cough & Chest Congestion

Tos y Congestion de Pecho

Alcohol Free. Sugar Free. Dye Free. Non-Drowsy

Sin Alcohol. Sin Azucar. Sin Colorantes. No causa sueno.

COUGH & COLD, CHEST CONGESTION, LIQUIFIES

AND LOOSSEN PHLEGM AND MUCUS

TOS Y CATARRO, CONGESTION DE PECHO,

LIQUA Y SUELTA LA FLEMA Y EL MOCO

RASBERRY FLAVOIR.

SABOR A FRAMBUESA. 4 FL OZ (118 ml)

INGREDIENTS AND APPEARANCE

GILTUSS CHILDRENS COUGH AND CHEST CONGESTION 
dextromethorphan hydrobromide, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65852-019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
CITRIC ACID (UNII: 2968PHW8QP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65852-019-04	1 in 1 CARTON	10/02/2018
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/02/2018

Labeler - Dextrum Laboratories, Inc (007392322)