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CapCof

Capital Pharmaceutical, LLC

CapCof


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Chlorpheniramine Maleate 2 mg

Codeine Phosphate* 10 mg

*(WARNING:  May be habit forming)

Phenylephrine Hydrochloride 5 mg

Purpose

Antihistamine

Antitussive

Nasal Decongestant

CapCof Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

  • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • a breathing problem such as emphysema
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • be careful when driving a motor vehicle or operating machinery
  • may cause or aggravate constipation

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1week, tends to recur, or is accompanied by a fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.
  • new symptoms occur

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

Do not exceed recommended dosage.

Adults and children
12 years of age
and over:

2 teaspoonfuls
 (10 mL) every
4 hours, not to
exceed 12 teaspoonfuls
in 24 hours.
Children 6 to under
12 years of age:


1 teaspoonful
(5 mL) every
4 hours,
not to exceed
6 teaspoonfuls in
24 hours.
Children under
6 years of age:
Consult a doctor

A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.  Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

CapCof Other information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

Citric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions? Comments?

Call 1-614-638-4622.

CV

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side pane for 473 mL label:

NDC 29978-420-16

CapCof

Antihistamine · Antitussive · Nasal Decongestant

Each 5 mL (one teaspoonful) for oral

administration contains:

Chlorpheniramine Maleate........................2 mg

Codeine Phosphate*...............................10 mg

*(WARNING-May be habit forming)

Phenylephrine Hydrochloride....................5 mg

Alcohol Free · Gluten Free

Sugar Free · Dye Free


Cotton Candy Flavor

CV

CAPITAL pharmaceutical

16 fl oz. (473 mL)

Tamper evident by foil seal under cap.  Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container with a child-resistant cap.

THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.

Manufactured by:  Pernix Manufacturing, LLC, Houston, TX  77099

Manufactured for:  Capital Pharmaceutical, LLC, Powell, OH  43065


Iss. 10/13

CapCof

CapCof

CapCof

Codeine Phosphate, Phenylephrine Hydrochloride, Chlorpheniramine Maleate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:29978-420
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CODEINE PHOSPHATE CODEINE ANHYDROUS 10 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:29978-420-16 473 in 1 BOTTLE
2 NDC:29978-420-15 15 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-10-08


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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