GILTUSS TR- guaifenesin,dextromethorphan hbr,phenylephrine hcl tablet

Giltuss TR by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredients(in each tablet)

Guaifenesin 390 mg.

Dextromethorphan HBr 29 mg.

Phenylephrine HCl 10 mg.

Purposes

Expectorant

Antitussive

Nasal Decongestant

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

Do not usethis 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.

PREGNANCY OR BREAST FEEDING

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.

KEEP OUT OF REACH OF CHILDREN

Directions 

Do not exceed recommended doses in a 24 hour period

• Adults and Children 12 years and over:1 tablet every 6 to 8 hours. Do not exceed 4 tablets in 24 hours.
• Children 6 to 12 years:1/2 tablet every 6 to 8 hours. Do not exceed 2 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 Ingredients

Hydroxypropyl Methylcellulose, Magnesium Stearate, Maltodextrin, Microcrystalline  Cellulose, Polyethylene Glycol, Povidone, Silicone Dioxide and Stearic Acid.

Questions? Call 787-848-9114

Manufactured for:

GIL PHARMACEUTICAL CORP.

Ponce, Puerto Rico 00716

Label revised: 04/22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Giltuss ®Total Release - NDC-58552-335-01 - 100's Bottle Label.

INGREDIENTS AND APPEARANCE

GILTUSS TR 
guaifenesin,dextromethorphan hbr,phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-335
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	390 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	29 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	303;Gil
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-335-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/07/2022
2	NDC: 58552-335-02	2 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/07/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/07/2022

Labeler - Gil Pharmaceutical Corp (176826592)

Registrant - Syntho Pharmaceuticals, Inc (113616187)

Establishment
Name	Address	ID/FEI	Business Operations
Syntho Pharmaceuticals, Inc.		088797407	manufacture(58552-335)