GILTUSS EX EXPECTORANT- guaifenesin solution 
Gil Pharmaceutical Corp

----------

Giltuss EX Expectorant

Drug Facts

Active ingredient (in each 10 mL)

Guaifenesin, 400 mg

Purpose

Expectorant

Uses

Warnings

Ask a doctor before use if you have

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

Stop use and ask a doctor ifcough 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.

If pregnant or breast-feeding, ask a health professional before use.

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

Directions

Other information

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

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.

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

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

MAXIMUM STRENGTH

Giltuss® EX EXPECTORANT

ALCOHOL FREE. SUGAR FREE. DYE FREE. NON-DROWSY

RELIEVES

CHEST CONGESTION

LOOSENS AND LIQUIFIES PHLEGM

LIQUIFIES AND REMOVE MUCUS

HELPS TO EXPEL PHLEGM IN CHEST AND THROAT

TUTTI FRUTTI FLAVOR

4FL OZ (118 mL)

58552-145

GILTUSS EX EXPECTORANT 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-145
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
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
Color    Score    
ShapeSize
FlavorTUTTI FRUTTIImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-145-041 in 1 CARTON06/22/2020
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/22/2020
Labeler - Gil Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIBusiness Operations
Dextrum Laboratories Inc007392322manufacture(58552-145)

Revised: 10/2023
Document Id: 08757ae7-755a-793a-e063-6394a90a2b58
Set id: a8c53c14-ba82-2c68-e053-2a95a90a9894
Version: 4
Effective Time: 20231024
 
Gil Pharmaceutical Corp