CARBAPHEN CH - chlophedianol hydrochloride, chlorpheniramine maleate and phenylephrine hydrochloride suspension
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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Active ingredient

Chlophedianol HCl 24 mg

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

Purpose

Antitussive

Antihistamine

Nasal Decongestant

Uses

Temporarily relieves:

cough due to the common cold.
runny nose and sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.
nasal congestion due to the common cold.

Warnings

Do not use

in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if you have

asthma
emphysema
glaucoma
diabetes
excessive phlegm (mucus)
breathing problems
chronic bronchitis
persistent or chronic cough
cough associated with smoking
trouble urinating due to enlarged prostate gland
a sodium-restricted diet
thyroid disorders
heart disease
high blood pressure

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

do not use more than directed
excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts, or sleeplessness. These could be signs of a serious condition.

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.

Directions

use 5 mL dose cup or teaspoon
do not exceed 4 doses in 24 hours

Adults and children 12 years of age and older:	5 mL [1 teaspoon] every 6 to 8 hours.
Children 6 to 12 years of age:	2.5 mL [1/2 teaspoon] every 6 to 8 hours.
Children under 6 years of age:	Consult a doctor.

Other information

store at room temperature

Inactive ingredients

banana flavor, benzoic acid, blueberry flavor, citric acid, ethyl alcohol, glycerin, methylparaben, natural masking agent, propylene glycol, propylparaben, sodium citrate, sorbital, sucralose, water, and xanthan gum.

Questions

Call Gil Pharmaceuticals Corp. at 787-848-9114, Mon.-Fri. 8:00 am to 5:00 pm, EST.

Manufactured for:

GIL Pharmaceuticals Corp.

Ponce, Puerto Rico 00716

PI383

Rev. 12/11

7185

Package/Label Principal Display Panel

NDC 58552-127-16

CARBAPHEN CH®

Great Blueberry Banana Flavor Suspension

ANTITUSSIVE, ANTIHISTAMINE, AND NASAL DECONGESTANT

New Improved FORMULA!

SUGAR FREE

Each 5 mL contains:

Chlophedianol HCI........................24 mg

Chlorpheniramine Maleate..............4 mg

Phenylephrine HCI.........................10 mg

1 Pint (473 mL)

MANUFACTURED FOR:

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00716

CARBAPHEN CH
chlophedianol hcl, chlorpheniramine maleate, and phenylephrine suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58552-127
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOPHEDIANOL HYDROCHLORIDE (CHLOPHEDIANOL)	CHLOPHEDIANOL HYDROCHLORIDE	24 mg in 5 mL
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE)	CHLORPHENIRAMINE MALEATE	4 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	10 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID
ANHYDROUS CITRIC ACID
ALCOHOL
GLYCERIN
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
SODIUM CITRATE
SORBITOL
SUCRALOSE
WATER
XANTHAN GUM

Product Characteristics
Color		Score
Shape		Size
Flavor	BLUEBERRY, BANANA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:58552-127-16	473 mL in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/29/2011

Labeler - Gil Pharmaceutical Corp (176826592)

Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)

Establishment
Name	Address	ID/FEI	Operations
Nexgen Pharma, Inc.		833205789	MANUFACTURE

Revised: 01/2012 Gil Pharmaceutical Corp