Carbaphen Ped CH description, usages, side effects, indications, overdosage, supplying and lots more!

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Carbaphen Ped CH

Gil Pharmaceutical Corp

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Carbaphen Ped CH 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.

Carbaphen Ped CH 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

Carbaphen Ped CH

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 label Item Code (Source) NDC:58552-128
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlophedianol Hydrochloride Chlophedianol 8 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 1.25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
ANHYDROUS CITRIC ACID
ALCOHOL
GLYCERIN
METHYLPARABEN
propylene glycol
PROPYLPARABEN
SODIUM CITRATE
sorbitol
Sucralose
water
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 NDC:58552-128-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-03-29


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Be sure to consult your doctor before taking any medication!
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