GILTUSS TR- guaifenesin,dextromethorphan hbr,phenylephrine hcl tablet 
Syntho Pharmaceuticals, Inc.

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.

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GILTUSS ® TOTAL RELEASE

EXPECTORANT, ANTITUSSIVE AND NASAL DECONGESTANT>

SUGAR FREE AND PRESERVATIVE FREE

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 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

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

Manufactured by:
Syntho Pharmaceuticals, Inc.
Farmingdale, New York (NY) 11735
Label revised: 04/22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Giltuss ® Total Release - NDC-66576-335-01 - 100's Bottle Label.

image description

GILTUSS TR 
guaifenesin,dextromethorphan hbr,phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66576-335
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN390 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE29 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeOVALSize8mm
FlavorImprint Code 303;Gil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66576-335-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/07/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/07/2022
Labeler - Syntho Pharmaceuticals, Inc. (088797407)

Revised: 6/2022
Document Id: e1502b49-a051-2c07-e053-2995a90a3151
Set id: bb7098fc-458f-47ed-8d09-7581d8eb17ec
Version: 1
Effective Time: 20220613
 
Syntho Pharmaceuticals, Inc.