GILTUSS SINUS AND CHEST CONGESTION- guaifenesin, phenylephrine hcl tablet

Giltuss Sinus and Chest Congestion by

Drug Labeling and Warnings

Giltuss Sinus and Chest Congestion by is a Otc medication manufactured, distributed, or labeled by Gil Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active Ingredient (in each tablet)

Guaifenesin 388 mg

Phenylephrine HCl 10 mg

PURPOSE

Purpose

Expectorant

Nasal Decongestant

INDICATIONS & USAGE

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
• clears stuffy nose
• clear nasal passageways
• shrinks swollen membranes

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

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Other information

• store at room temperature, USP
• do not use if blister seal is broken

INACTIVE INGREDIENT

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

Questions? Call 787-848-9114

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MANUFACTURED FOR GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

GILTUSS®

SINUS & CHEST CONGESTION

20 TABLETS

NON-DROWSY. DYE FREE. PRESERVATIVE . SODIUM FREE

RELIEVES

• STUFFY NOSE
• NASAL CONGESTION
• SINUS PRESSURE
• CHEST CONGESTION
• LOOSENS PHLEGM AND MUCUS

INGREDIENTS AND APPEARANCE

GILTUSS SINUS AND CHEST CONGESTION 
guaifenesin, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-332
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, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	19mm
Flavor		Imprint Code	GILGIL;304304
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-332-20	2 in 1 CARTON	11/02/2018
1		10 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	11/02/2018

Labeler - Gil Pharmaceutical Corp (176826592)