GILPHEX- guaifenesin, 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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GILPHEX ® TOTAL RELEASE

EXPECTORANT AND NASAL DECONGESTANT



YEAST FREE

SODIUM FREE

GLUTEN FREE

PRESERVATIVE FREE

SUGAR FREE

Drug Facts

Active Ingredients (in each tablet)

Guaifenesin 390 mg
Phenylephrine HCl 10 mg

Purposes

Expectorant

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, 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

Stop use and ask a doctor If

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 or 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


Inactive Ingredients

Hydroxypropyl Methylcellulose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Silicone Dioxide, 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
Revised Label: 03-22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gilphex ® Total Release - NDC-66576-336-01 - 100's Bottle Label

image description

GILPHEX 
guaifenesin, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66576-336
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN390 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
ShapeCAPSULESize8mm
FlavorImprint Code 304;Gil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66576-336-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/05/2022
Labeler - Syntho Pharmaceuticals, Inc. (088797407)

Revised: 6/2022
Document Id: e1501276-6d45-6ae8-e053-2a95a90abfa7
Set id: 87d867fd-e78d-4fbd-a5e4-5fcbb70559a3
Version: 1
Effective Time: 20220613
 
Syntho Pharmaceuticals, Inc.