4060-Gil

4060-Gil

Drug Labeling and Warnings

Drug Details

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GILTUSS TOTAL RELEASE- guaifenesin, dextromethorphan hbr, and phenylephrine hcl tablet, film coated 
Gil Pharmaceutical Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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4060-Gil

Drug Facts

Active Ingredients (in each tablet)

Guaifenesin 388 mg

Dextromethorphan HBr 28 mg

Phenylephrine HCl 10 mg

Purposes

Expectorant

Antitussive

Nasal Decongestant

Uses

  • temporarily relieves these 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
  • clears stuffy nose
  • clear nasal passageways
  • shrinks swollen membranes

Do not use this product 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

Do not exceed recommended doses in a 24 hour period

Adults and Children 12 years and over: 1 tablet every 6 to 8 hours. Do not exceed 4 tablets in 24 hours.

Children 6 to 12 years: 1/2 tablet every 6 to 8 hours. Do not exceed 2 tablets in 24 hours.

Children under 6 years of age: ask a doctor

Other Information

  • store at room temperature, USP
  • do not use if imprinted safety seal under cap is broken or missing.

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?

Call 787-848-9114


Manufactured for:

GIL PHARMACEUTICAL CORP.

Ponce, Puerto Rico 00717-1565


NDC: 58552-317-01

GILTUSS ®

TOTAL RELEASE

EXPECTORANT, ANTITUSSIVE, AND NASAL DECONGESTANT

SUGAR FREE AND PRESERVATIVE FREE

Each scored tablet contains:

Guaifenesin................................388 mg.

Dextromethorphan HBr................28 mg.

Phenylephrine HCl........................10 mg.

100 Tablets

MANUFACTURED FOR:

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00716

4060-gil-label

GILTUSS TOTAL RELEASE 
guaifenesin, dextromethorphan hbr, and phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58552-317
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TALC (UNII: 7SEV7J4R1U)  
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
ShapeOVALSize15mm
FlavorImprint Code GIL;303
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58552-317-0212 in 1 CARTON07/15/2011
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 58552-317-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/27/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/19/2009
Labeler - Gil Pharmaceutical Corp (176826592)

Revised: 10/2018
 
Gil Pharmaceutical Corp


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