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 Gil Pharmaceutical Corp, Dextrum Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL)

Guaifenesin, 200 mg

PURPOSE

Purpose

Expectorant

INDICATIONS & USAGE

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

WARNINGS

Warnings

Ask a doctor before use if your child has

• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with asthma or chronic bronchitis

Stop use and ask a doctor if the child hasa cough that lasts for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• do not take more than 6 doses in any 24-hour 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

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredientscitric acid, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.

QUESTIONS

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.

SPL UNCLASSIFIED SECTION

Tamper Evident: do not use if safety seal is broken or missing.

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

PRINCIPAL DISPLAY PANEL

Children 4-12

Children's Giltuss® EX EXPECTORANT

Alcohol Free, Sugar Free. Dye Free, Non Drowsy

CHEST CONGESTION

LIQUIFIES AND LOOSENS PHLEGM

LIQUIFIES AND REMOVES MUCUS

TUTTI FRUTTI FLAVOR

4FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS GILTUSS EX EXPECTORANT 
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-146
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: 58552-146-04	1 in 1 CARTON	06/22/2020
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 Drug	M012	06/22/2020

Labeler - Gil Pharmaceutical Corp (176826592)

Establishment
Name	Address	ID/FEI	Business Operations
Dextrum Laboratories Inc		007392322	manufacture(58552-146)