ENDACOF  C- chlorpheniramine maleate and codeine phosphate liquid 
Larken Laboratories, Inc.

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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EndaCof C

Drug Facts

Active ingredients (in each 5 mL teaspoonful)

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

Codeine Phosphate* …………………….. 10 mg

*(Warning: May be habit-forming)

Purpose

Chlorpheniramine Maleate ……... Antihistamine

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

Uses

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.

Warnings

Do not exceed recommended dosage.

Do not use

  • 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

Ask a doctor before use if you have:

  • 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

Ask a doctor or pharmacist before use if you are taking:

  • sedatives or tranquilizers

When using this product:

  • 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

Stop use and ask a doctor if:

  • 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.

If pregnant or breastfeeding

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 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

Other information

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

Inactive Ingredients

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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

091acdd1-figure-01
ENDACOF   C
codeine phosphate and chlorpheniramine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-149
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68047-149-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/25/200911/10/2015
Labeler - Larken Laboratories, Inc. (149484540)
Establishment
NameAddressID/FEIBusiness Operations
TG United Liquid, Inc.830980947manufacture(68047-149)

Revised: 11/2015
 
Larken Laboratories, Inc.