Carbaphen CH

Dosage form: suspension
Ingredients: CHLOPHEDIANOL HYDROCHLORIDE 24mg in 5mL, CHLORPHENIRAMINE MALEATE 4mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 5mL
Labeler: Gil Pharmaceutical Corp
NDC Code: 58552-127

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.

Drug Facts

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:58552-127
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOPHEDIANOL HYDROCHLORIDE (CHLOPHEDIANOL) CHLOPHEDIANOL HYDROCHLORIDE24 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
ANHYDROUS CITRIC ACID 
ALCOHOL 
GLYCERIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
WATER 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorBLUEBERRY, BANANAImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58552-127-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/29/2011
Labeler - Gil Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIOperations
Nexgen Pharma, Inc.833205789MANUFACTURE(58552-127)

Revised: 03/2012
 
Gil Pharmaceutical Corp

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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