PHENAGIL CH- phenyleprine hcl, chlorpheniramine maleate and chlophedianol hcl tablet 
Gil Pharmaceutical Corp

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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4130-Gil-Phenagil CH

Drug Facts

Active Ingredients (in each tablet)


Chlorpheniramine Maleate 3.5 mg
Phenylephrine HCl 10 mg
Chlophedianol HCl 24 mg

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.

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.

Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose and Silica.

Questions? Call 787-848-9114


Manufactured for: GIL PHARMACEUTICAL CORP.
Ponce, Puerto Rico 00716

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

Gil label

PHENAGIL CH 
phenyleprine hcl, chlorpheniramine maleate and chlophedianol hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-323
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE24 mg
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)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code GIL;323
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-323-0212 in 1 BOX06/17/2015
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:58552-323-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/17/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/17/2015
Labeler - Gil Pharmaceutical Corp (176826592)
Registrant - Contract Pharmacal Corp. (057795122)

Revised: 12/2020
Document Id: b7b4bf85-8a11-4b0f-e053-2a95a90abf05
Set id: 69f86794-cb83-8f21-e053-2a91aa0af778
Version: 2
Effective Time: 20201230
 
Gil Pharmaceutical Corp