PHENAGIL CH- phenyleprine hcl, chlorpheniramine maleate and chlophedianol hcl tablet

Phenagil CH by

Drug Labeling and Warnings

Phenagil CH by is a Otc medication manufactured, distributed, or labeled by Gil Pharmaceutical Corp, Contract Pharmacal Corp.. 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
Chlophedianol HCl 24 mg

PURPOSE

Purposes

Antihistamine
Nasal Decongestant
Cough Suppressant

Uses

Uses

Temporarily relieves runny nose and alleviates sneezing, itchy, watery eyes due to hay fever or other upper respiratory allergies. Temporarily relieves nasal congestion due to the common cold. Temporarily controls cough due to minor bronchial irritation occurring with the common cold.

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

persistent or chronic cough such as occurs with smoking, asthma

chronic bronchitis, or emphysema

excessive phlegm (mucus)

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

cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache

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

• Adults and Children 12 years of age and over: take 1 tablet every 6 hours. Do not exceed 4 tablets in 24 hours
• Children 6 to under 12 years of age:

  take 1/2 tablet every 6 hours as needed.

  Do not exceed 2 tablets in 24 hours

• Children under 6 years of age: Consult a physician.

Other information

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

INACTIVE INGREDIENT

Croscarmellose Sodium, 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: 58552-323-01

PHENAGIL® CH

ANTIHISTAMINE, NASAL DECONGESTANT AND ANTITUSSIVE
SUGAR FREE AND DYE FREE
Each tablet contains:
Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCI 10 mg
Chlophedianol HCl 24 mg

100 Tablets

MANUFACTURED FOR
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00716

INGREDIENTS AND APPEARANCE

PHENAGIL CH 
phenyleprine hcl, chlorpheniramine maleate and chlophedianol hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-323
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
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	24 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	GIL;323
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-323-02	12 in 1 BOX	06/17/2015
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 58552-323-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/17/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/17/2015

Labeler - Gil Pharmaceutical Corp (176826592)