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

----------

Giltuss Cough & Cold

Drug Facts

Active ingredients (in each 5 mL)

Dextromethorphan HBr, 15 mg

Guaifenesin, 300 mg

Phenylephrine HCI, 10 mg

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

Uses

Warnings

Do not useif you are 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease, high blood pressure, thyroid disease, or diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you aretaking any other oral nasal decongestant or stimulant, sedatives, tranquilizers, and drugs for depression, especially monoamine oxidase inhibitors (MAOIs).

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistant headache

These can 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 accident overdose, get medical or professional help or contact a Poison Control Center immediately.

Directions

adults and children 12 years & over5 mL every 4 hours
children 6 to under 12 years of age2.5 mL every 4 hours
children 2 to 6 years of age1.25 mL every 4 hours
children under 2 years of ageConsult a doctor

Other information

Inactive ingredientsCitric acid, flavor, glycerin, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, 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.

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

MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

MAXIMUM STRENGTH

GILTUSS®

COUGH & COLD

ALCOHOL FREE. SUGAR FREE. DYE FREE

RELIEVES

4 FL OZ (118 mL)

58552-130

GILTUSS COUGH AND COLD 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-130
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN300 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-130-041 in 1 CARTON10/02/2018
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 DrugM01210/02/2018
Labeler - Gil Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIBusiness Operations
Dextrum Laboratories Inc.007392322manufacture(58552-130)

Revised: 10/2023
Document Id: 08751c7f-e001-8f9d-e063-6394a90a30af
Set id: 8503c956-42a5-7684-e053-2991aa0adb27
Version: 4
Effective Time: 20231024
 
Gil Pharmaceutical Corp