GILPHEX TR - guaifenesin and phenylephrine hydrochloride tablet 
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.

----------

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

Warnings

Do not use

  • more than the recommended dosage
  • this product 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

Inactive ingredients

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 00717-1565


Rev. 05/11

Package/Label Principal Display Panel

Image of Container Label - 100 Tablets

NDC: 58552-313-01

GILPHEX TOTAL RELEASE

EXPECTORANT AND NASAL DECONGESTANT

DYE FREE AND PRESERVATIVE FREE

Each scored tablet contains:

Guaifenesin 388 mg

Phenylephrine HCl 10 mg

100 Tablets

MANUFACTURED FOR:

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565


GILPHEX TR 
guaifenesin and phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-313
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN388 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
HYPROMELLOSE 2910 (6 MPA.S) 
LACTOSE 
MAGNESIUM SILICATE 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POVIDONE K30 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
POLYETHYLENE GLYCOL 400 
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize15mm
FlavorImprint Code GIL;304
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:58552-313-01100 TABLET in 1 BOTTLENone
2NDC:58552-313-0212 BLISTER PACK in 1 CARTONcontains a BLISTER PACK
22 TABLET in 1 BLISTER PACKThis package is contained within the CARTON (58552-313-02)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/12/2008

Labeler - Gil Pharmaceutical Corp (176826592)
Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corporation968334974MANUFACTURE

Revised: 10/2011 Gil Pharmaceutical Corp