PHENAGIL- phenylephrine hcl and chlorpheniramine maleate tablet 
Gil Pharmaceutical Corp

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4131-Gil-Phenagil

Drug Facts

Active Ingredients (in each tablet)

Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCl 10 mg

Purposes
Antihistamine
Nasal Decongestant

Uses

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

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 use if you are

taking sedatives or tranquilizers

When using this product

• do not exceed recommended dose

• excitability may occur, especially in children

• drowsiness may occur

• alcohol, sedatives, and tranquilizers may increase drowsiness

• avoid alcoholic drinks

• be careful when driving a motor vehicle or operating machinery

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 the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Adults and Children12 years of age and over:take 1 tablet every 4-6 hours. Do not exceed 6 tablets in 24 hours
Children 6 to under 12 years of age:1/2 tablet every 4-6 hours, not to exceed 3 tablets in a 24 our period
Children under 6 years of age:Consult a physician.


Other Informaton

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

Magnesium Stearate, Microcrystalline Cellulose and Silica.

Questions? Call 787-848-9114
Manufactured for: GIL PHARMACEUTICAL CORP. Ponce, Puerto Rico 00716

NDC 58552-322-01
PHENAGIL

ANTIHISTAMINE AND NASAL DECONGESTANT

SUGAR FREE AND DYE FREE

Each tablet contains:
Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCI 10 mg

100 Tablets

MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00716

4131-label

PHENAGIL 
phenylephrine hcl and chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-322
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE3.5 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 322;GIL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-322-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2012
2NDC:58552-322-0212 in 1 BOX12/14/2012
22 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01212/14/2012
Labeler - Gil Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIBusiness Operations
Syntho Pharmaceuticals Inc088797407manufacture(58552-322)

Revised: 10/2023
Document Id: 0875d715-7070-0155-e063-6294a90a3cec
Set id: 69fd13a1-2b76-8574-e053-2a91aa0a27e7
Version: 6
Effective Time: 20231024
 
Gil Pharmaceutical Corp