CARBAPHEN CH- chlophedianol hcl, chlorpheniramine maleate, and phenylephrine 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

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

Image of Container Label - 473 mL

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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE24 mg  in 5 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBLUEBERRY, BANANAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58552-127-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/29/201103/28/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/29/201103/28/2019
Labeler - Gil Pharmaceutical Corp (176826592)
Establishment
NameAddressID/FEIBusiness Operations
Nexgen Pharma, Inc.806784679manufacture(58552-127)

Revised: 3/2019
Document Id: 852e4837-5e77-ced6-e053-2a91aa0abaac
Set id: c032041e-fa67-4ef8-aa5a-82d5b0432178
Version: 3
Effective Time: 20190328
 
Gil Pharmaceutical Corp