GILTUSS EX EXPECTORANT- guaifenesin solution 
Dextrum Laboratories Inc.

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Giltuss EX Expectorant

Active Ingredients

Active Ingredients

Guafenesin, 400 mg Active ingredients

Uses

Purpose

Expectorant

Uses

Warnings

Warnings

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 Stop use

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 If pregnant

Directions

Directions

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

Use enclosed dosing cup Directions

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 Other information

Inactive Ingredients

Inactive Ingredients

Citric acid, glycerin, methylparaben,natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, Inactive ingredients 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 Questions

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

indication an user

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

Keep out

Principal panelMaximun 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

GILTUSS EX EXPECTORANT 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65852-008
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorTUTTI FRUTTIImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65852-008-041 in 1 CARTON06/22/2020
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/22/2020
Labeler - Dextrum Laboratories Inc. (007392322)

Revised: 9/2025
Document Id: 3f67ac3d-1504-3418-e063-6394a90a938f
Set id: 3f67ac3d-1503-3418-e063-6394a90a938f
Version: 1
Effective Time: 20250922
 
Dextrum Laboratories Inc.