GILTUSS COUGH AND COLD- dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet

Giltuss Cough and Cold by

Drug Labeling and Warnings

Giltuss Cough and Cold 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 Ingredients (in each tablet)

Dextromethorphan HBr, 28 mg

Guaifenesin, 388 mg

Phenylephrine HCl, 10 mg

PURPOSE

Purposes

Antitussive

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, clear stuffy nose, clear nasal passageways, and shrinks swollen membranes.

WARNINGS

Warnings

Do not use 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.

DOSAGE & ADMINISTRATION

Directions

Adults and Children 12 years and over: Take 1 tablet every 6 to 8 hours. Do not take more than 4 tablets in a 24 hour period.

Children 6 to 12 years of age: Take 1/2 tablet every 6 to 8 hours. Do not take more than 2 tablets in a 24-hour period.

Children under 6 years of age: Consult a physician.

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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, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.

QUESTIONS

Questions or Comments? Call 787-848-9114, Mon.-Fri. 9:00 a.m. thru 5:00 p.m. EST. Call your doctor for medical advice in the event of side effects.

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MANUFACTURED FOR GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

Giltuss ®

COUGH & COLD

20 TABLETS
SUGAR FREE. DYE FREE. PRESERVATIVE FREE.

RELIEVES

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

INGREDIENTS AND APPEARANCE

GILTUSS COUGH AND COLD 
dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-331
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	388 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	28 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
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)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	19mm
Flavor		Imprint Code	GILGIL;303303
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-331-20	2 in 1 CARTON	10/11/2018
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	10/11/2018

Labeler - Gil Pharmaceutical Corp (176826592)