GILTUSS EX EXPECTORANT- guaifenesin solution

Giltuss EX Expectorant by

Drug Labeling and Warnings

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

Guafenesin, 400 mg

Uses

Purpose

Expectorant

Uses

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

Warnings

Warnings

• Ask a doctor before use if you have , cough that occurs with too much phlegm ( mucus) , persistent or chronic cough such occurs with smoking, asthma, or chronic bronchitis or emphysema
  

Stop Use

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

If pregnant or breast -feeding

If pregnant or breast- feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poisson Control center immediately

Directions

Directions

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

Use enclosed dosing cup

Keep dosing cup for use this product

ml= mililiters

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

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

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

children under 4 years of age Consult a doctor

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 and comments

Questions and comments?

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

call your doctor for medical advice in the event of side effects

Indication and user section

Indication and usage

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

Keep sosage cup for use with this product

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

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

Children 4 to under 6 years of age 2.5ml ever 4 hours

Children under 4 years of age Consult a doctor

Keep out of reach of children

Keep out of reach of children.

In case of accidental overdose, get medical or professional help or contact a Poison Control center immediately

PRINCIPAL DISPLAY PANEL

Maximun strength Giltuss EX Expectorant

Guafenesin 400 mg

Alcohol free, sugar free, Dye free, Non-Drowsy

Chest congestion, Phlegm & Mucus

Tutti Frutti Flavor

4 floz 118 ml

INGREDIENTS AND APPEARANCE

GILTUSS EX EXPECTORANT 
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65852-008
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: 65852-008-04	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)