GILPHEX TR- guaifenesin and phenylephrine hcl tablet, film coated

Gilphex TR by

Drug Labeling and Warnings

Gilphex TR by is a Otc medication manufactured, distributed, or labeled by Gil Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Guaifenesin 388 mg

Phenylephrine HCl 10 mg

PURPOSE

Purpose

Expectorant

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

WARNINGS

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 4 hours. Do not exceed 6 tablets in 24 hours.
• Children 6 to 12 years: 1/2 tablet every 4 hours. Do not exceed 3 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

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

Manufactured for:

GIL PHARMACEUTICAL CORP.,

Ponce, Puerto Rico 00716

PRINCIPAL DISPLAY PANEL

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 00716

INGREDIENTS AND APPEARANCE

GILPHEX TR 
guaifenesin and phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-313
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	388 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
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)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	19mm
Flavor		Imprint Code	GIL;GIL;304;304
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-313-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/13/2011
2	NDC: 58552-313-02	12 in 1 CARTON	07/15/2011
2		2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/12/2008

Labeler - Gil Pharmaceutical Corp (176826592)