GILPHEX TR- guaifenesin 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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4062-Gil

Drug Facts

Active ingredient (in each tablet)

Guaifenesin 388 mg

Phenylephrine HCl 10 mg

Purpose

Expectorant

Nasal Decongestant

Uses

temporarily relieves these symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies

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

Other information

Croscarmellose Sodium, Hypromellose, Lactose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.

Questions?

Call 787-848-9114


Manufactured for:

GIL PHARMACEUTICAL CORP.,

Ponce, Puerto Rico 00716


GILPHEX TR

Guaifenecin, Phenylephrine

GILPHEX® TR the brand physicians trust in a convenient TOTAL RELEASE formula for TOTAL RELIEF of CONGESTION! EXPECTORANT AND NASAL DECONGESTANT

DYE FREE AND PRESERVATIVE FREE TABLETS

MANUFACTURED FOR:

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00716

Gil label

GILPHEX TR 
guaifenesin and phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-313
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN388 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
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)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize19mm
FlavorImprint Code GIL;GIL;304;304
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-313-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/13/2011
2NDC:58552-313-0212 in 1 CARTON07/15/2011
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/12/2008
Labeler - Gil Pharmaceutical Corp (176826592)

Revised: 12/2020
Document Id: b6a0f6e2-7b3d-6192-e053-2a95a90aa6a0
Set id: 80a33cba-9577-402a-84bc-1507c439c933
Version: 4
Effective Time: 20201216
 
Gil Pharmaceutical Corp