CHILDRENS GILTUSS EX EXPECTORANT- guaifenesin solution

Childrens Giltuss EX Expectorant by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Active ingredients ( in each 5 ml) Purpose

Guaifenesin, 200 mg ----------------------------------------Expectorant

Uses

Warnings

Stop use section

Keep out of reach of children

Directions

Directions

Do not take more than 6 doses in any 24 hours period

use enclosed dosing cup

Keep dosage cup for use with this product

ml= mililiters

children under 4 years of age Consult a doctor

children 4 to under 6 years of age 2.5 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

Adults and children 12 years & over 10 ml every 4 hours

Other Information

Other information

Store at room temperature 15-30 °C (59° -86 ° F)
Close cap tightly
SAVE CARTON FOR COMPLETE DRUG FACTS

Inactive Ingredients

Inactive Ingredients

Citric Acid, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions or comments

Questions or comments?

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

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

indication for use section

indication an user section

Do not take more than 6 doses in any 24 hours period

use enclosed dosing cup

Keep dosage cup for use with this product

ml= mililiters

children under 4 years of age Consult a doctor

children 4 to under 6 years of age 2.5 ml every 4 hours

children 6 to under 12 years of age 5 ml every 4 hours

Adults and children 12 years & over 10 ml every 4 hours

PRINCIPAL DISPLAY PANEL

Children 4 -12

Children's Giltuss EX

Expectorant

Guaifenesin, 200 mg

Alcohol free, Sugar free, Dye free, Non-Drowsy

Chest congestion liquifies and loosen phlegm and mucus

Tutti Frutti flavor

4 floz 118 ml

INGREDIENTS AND APPEARANCE

CHILDRENS GILTUSS EX EXPECTORANT 
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65852-016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	TUTTI FRUTTI	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65852-016-04	1 in 1 CARTON	06/22/2020
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	06/22/2020

Labeler - Dextrum Laboratories Inc. (007392322)