PHENAGIL- phenylephrine hcl and chlorpheniramine maleate tablet

PHENAGIL by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredients (in each tablet)

Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCl 10 mg

PURPOSE

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

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 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.

INACTIVE INGREDIENT

Magnesium Stearate, Microcrystalline Cellulose and Silica.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

PHENAGIL 
phenylephrine hcl and chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-322
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	3.5 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	322;GIL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-322-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/14/2012
2	NDC: 58552-322-02	12 in 1 BOX	12/14/2012
2		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/14/2012

Labeler - Gil Pharmaceutical Corp (176826592)