GILTUSS DIABETIC COUGH AND COLD- dextromethorphan hydrobromide, guaifenesin solution 
Gil Pharmaceutical Corp

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Giltuss Diabetic Cough and Cold

Drug Facts

Active ingredients (in each 10 mL)

Dextromethorphan HBr, 20 mg

Guaifenesin 200 mg

Purposes

Cough Suppressant

Expectorant

Uses

Warnings

Do not use

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOl drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

When using this product do not use more than directed

Ask a doctor before use if you have

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

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or headache that lasts as these could be signs of a serious condition.

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 Poison Control Center immediately.

Directions

Adults and children 12 years and over10 mL every 4 hours
children 6 to under 12 years of age5 mL every 4 hours
children 2 to under 6 years of age2.5 mL every 4 hours
children under 2 years of ageDo not use

Other information

Inactive ingredients:Citric acid, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water and 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.

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

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

PERSONS WITH DIABETES: CONSULT YOUR DOCTOR OR PHARMACIST BEFORE USING ANY MEDICATION OR DIETARY SUPPLEMENT

THIS PRODUCT DOES NOT CONTAIN ANY MEDICATION TO IMPROVE OR RELIEVE DIABETES

Giltuss® DIABETIC

COUGH & COLD

RELIEVES

SAFE FOR PEOPLE WITH DIABETES

GRAPE FLAVOR

4 FL OZ (118 mL)

58552-134

GILTUSS DIABETIC  COUGH AND COLD
dextromethorphan hydrobromide, guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-134
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-134-041 in 1 CARTON10/17/2018
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 DrugM01210/17/2018
Labeler - Gil Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIBusiness Operations
Dextrum Laboratories Inc.007392322manufacture(58552-134)

Revised: 10/2023
Document Id: 08754bfc-ff96-e11e-e063-6394a90a6540
Set id: 85183b38-ce2a-0e0e-e053-2991aa0a336f
Version: 4
Effective Time: 20231024
 
Gil Pharmaceutical Corp