PHENAGIL- chlorpheniramine maleate,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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Relieve Allergy and Congestion with:

PHENAGIL ®ANTIHISTAMINE AND NASAL DECONGESTANT

DYE FREE

PRESERVATIVE FREE

SODIUM FREE

SUGAR FREE

Drug Facts

Active Ingredients (in each tablet)

Chlorpheniramine Maleate 3.5 mg

Phenylephrine HCl 10 mg

Purposes

Antihistamine

Nasal Decongestant

Uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper-respiratory allergies:

• runny nose.

• sneezing.

• itchy, watery eyes.

• nasal congestion.

• itching of the nose or throat.

• sinus congestion and pressure.

Warnings

Do not use 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease.
• high blood pressure.
• thyroid disease.
• diabetes.
• trouble urinating due to an enlarged prostate gland.
• a breathing problem such as emphysema or chronic bronchitis.
• glaucoma.

Ask a doctor or pharmacist before you use if you are taking sedatives or tranquilizers.

When using this product

Stop use and ask a doctor if

.• nervousness, dizziness, or sleeplessness occurs.
• symptoms do not improve within 7 days or occur with a fever.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Other information

• store at room temperature, USP.
• do not use if safety seal is broken or missing.

Inactive Ingredients

Hydroxypropyl Methylcellulose, Lactose Monohydrate, Magnesium Stearate,
Microcrystalline Cellulose and Polyethylene Glycol.

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

PHENAGIL- NDC- 66576-322-01- 100's Bottle Label.

image description

PHENAGIL 
chlorpheniramine maleate,phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66576-322
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE3.5 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 322;Gil
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66576-322-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/15/2022
Labeler - Syntho Pharmaceuticals, Inc. (088797407)

Revised: 6/2022
Document Id: e15024e7-870f-e0bf-e053-2a95a90a545f
Set id: 80200dc8-858e-43a4-965a-0ff7487046ad
Version: 1
Effective Time: 20220613
 
Syntho Pharmaceuticals, Inc.