GILTUSS COUGH AND COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet 
Gil Pharmaceutical Corp

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4060-Giltuss Cough & Cold Tablets

Drug Facts

Active Ingredients (in each tablet)

Dextromethorphan HBr, 28 mg

Guaifenesin, 388 mg

Phenylephrine HCl, 10 mg

Purposes

Antitussive

Expectorant

Nasal Decongestant

Uses

Temporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies. Helps loosen phlegm (mucus), loosens nasal congestion, thin bronchial secretions, drain bronchial tubes, make coughs more productive, clear stuffy nose, clear nasal passageways, and shrinks swollen membranes.

Warnings

Do not use more than the recommended dosage

  • or 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 MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, ask a health professional.

Ask a doctor before use if you have:

  • heart disease
  • excessive phlegm (mucus)
  • high blood pressure
  • diabetes
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if:

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus)
  • cough and congestion do not improve within 7 days or tend to recur

These could be signs of a serious condition.

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

Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

Adults and Children 12 years and over: Take 1 tablet every 6 to 8 hours. Do not take more than 4 tablets in a 24 hour period.

Children 6 to 12 years of age: Take 1/2 tablet every 6 to 8 hours. Do not take more than 2 tablets in a 24-hour period.

Children under 6 years of age: Consult a physician.

Other information

Inactive ingredients Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.

Questions or Comments? Call 787-848-9114, Mon.-Fri. 9:00 a.m. thru 5:00 p.m. EST. Call your doctor for medical advice in the event of side effects.

MANUFACTURED FOR GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

MAXIMUM STRENGTH

Giltuss ®

COUGH & COLD

20 TABLETS
SUGAR FREE. DYE FREE. PRESERVATIVE FREE.

RELIEVES

58552-331 Cough Cold Tabs 10-11-2018

GILTUSS COUGH AND COLD 
dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-331
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN388 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE28 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize19mm
FlavorImprint Code GILGIL;303303
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-331-202 in 1 CARTON04/01/2021
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/01/2021
Labeler - Gil Pharmaceutical Corp (176826592)

Revised: 10/2023
Document Id: 0876e6b6-0455-ec5b-e063-6394a90abf0e
Set id: 8590fcc9-c0dd-f43b-e053-2991aa0a692e
Version: 4
Effective Time: 20231024
 
Gil Pharmaceutical Corp