PHENAGIL- chlorpheniramine maleate,phenylephrine hcl tablet

PHENAGIL by

Drug Labeling and Warnings

PHENAGIL by is a Otc medication manufactured, distributed, or labeled by 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

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

• 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.

PREGNANCY OR BREAST FEEDING

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).

KEEP OUT OF REACH OF CHILDREN

Directions

• Adults and children 12 years and over.
  Take 1 tablet every 4 hours.
  Do not take more than 6 tablets in a 24 hours.
• Children 6 to 12 years of age:: Take 1/2 tablet every 4 hours, Do not to exceed 3 tablets in a 24 hour period.
• Do not use this product children under 6 years of age.

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.

INGREDIENTS AND APPEARANCE

PHENAGIL 
chlorpheniramine maleate,phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66576-322
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

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: 66576-322-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/15/2022

Labeler - Syntho Pharmaceuticals, Inc. (088797407)