CARBAPHEN PED CH- chlophedianol hcl, chlorpheniramine maleate and phenylephrine hcl 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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Carbaphen Pediatric

Active ingredient (in each 1 mL)

Chlophedianol HCl 8 mg

Chlorpheniramine Maleate 1.25 mg

Phenylephrine HCl 2.5 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 dosing syringe
do not exceed 4 doses in 24 hours

Children 6 to 12 years of age:	1 to 1.5 mL 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.

Package/Label Principal Display Panel

NDC 58552-128-02

Carbapen Ped CH®

New Improved FORMULA!

ANTITUSSIVE, ANTIHISTAMINE AND NASAL DECONGESTANT PEDIATRIC SUSPENSION

GREAT BLUEBERRY BANANA FLAVOR

Sugar Free

Easier Dosing for Children

Unique Dispenser for Exact Dosing

With Spill Guard Dispenser

Child Resistant Cap

Each 1 mL contains:

Chlophedianol HCl...............................8 mg

Chlorpheniramine Maleate...............1.25 mg

Phenylephrine HCl.............................2.5 mg

2 Fl. Oz. (60 mL)

MANUFACTURED FOR:

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00716

CARBAPHEN PED CH
chlophedianol hcl, chlorpheniramine maleate and phenylephrine hcl suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58552-128
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	8 mg in 1 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	1.25 mg in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58552-128-02	1 in 1 CARTON	03/29/2012	03/28/2019
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/29/2012	03/28/2019

Labeler - Gil Pharmaceutical Corp (176826592)

Name	Address	ID/FEI	Business Operations
Establishment
Nexgen Pharma, Inc.		806784679	manufacture(58552-128)

Revised: 3/2019

Document Id: 852e5c04-4751-17df-e053-2991aa0a6715

Set id: e01afa69-3911-4041-8256-71ac3e807a9c

Version: 2

Effective Time: 20190328

Gil Pharmaceutical Corp