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EndaCof

Larken Laboratories, Inc.




FULL PRESCRIBING INFORMATION

Drug Facts

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

Codeine Phosphate* …………………….. 10 mg

*(Warning: May be habit-forming)

Chlorpheniramine Maleate ……... Antihistamine

Codeine Phosphate ……………….…. Antitussive (Cough Suppressant)

temporarily relieves:

  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you go to sleep
  • temporarily decreases runny nose and sneezing, itching of the nose and throat and itchy, watery eyes due to hay fever or other respiratory allergies.

Do not exceed recommended dosage.

  • Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a doctor
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with excessive phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • sedatives or tranquilizers
  • do not use more than directed
  • constipation may occur or be aggravated
  • marked drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
  • symptoms last more than 7 days, come back or are accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

ask a health professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

Do not exceed recommended dosage.

  • Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 12 teaspoonfuls in a 24 hour period
  • Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in a 24 hour period.
  • Children under 6 years of age: Consult a doctor

Store at controlled room temperature, 59°- 86°F (15°-30°C) [see USP Controlled Room Temperature]

Citric Acid, Cotton Candy flavor, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose

Call 1-888-527-5522 weekdays from 9:00 a.m. to 4:00 p.m. CST or go to http://www.larkenlabs.com

EndaCof

EndaCof

Codeine Phosphate and Chlorpheniramine Maleate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68047-149
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 2 mg
CODEINE PHOSPHATE CODEINE ANHYDROUS 10 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
METHYLPARABEN
POTASSIUM CITRATE
POTASSIUM SORBATE
PROPYLPARABEN
propylene glycol
water
sorbitol
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68047-149-16 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-05-25


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Be sure to consult your doctor before taking any medication!
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