ENDACOF DC - codeine phosphate and pseudoephedrine hydrochloride liquid 
Larken Laboratories, Inc.

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EndaCof DC

Drug Facts

Active ingredients (in each 5 mL teaspoon)

Codeine Phosphate* …………………….. 10 mg

*(Warning: May be habit-forming)

Pseudoephedrine Hydrochloride ….. 30 mg

Purpose

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

Pseudoephedrine Hydrochloride ............................. Nasal Decongestant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants, reduces the intensity of coughing and suppresses the impulse to cough to help you rest. Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies (allergic rhinitis), reduces swelling of nasal passages, promotes nasal and/or sinus drainage and relieves sinus congestion and pressure.

Warnings

Do not exceed recommended dosage.

Do not use this product

Do not take this product, unless directed by a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breastfeeding,

ask a health professional before use.

Keep this and other drugs out of the 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 8 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 4 teaspoonfuls in a 24 hour period.

Children 2 to under 6 years of age: Consult a doctor

Other information

Store at controlled room temperature, 20°- 25°C (68°-77°F). Protect from freezing

Inactive Ingredients

Citric Acid, Fruit Gum Flavor, Propylene Glycol, Purified Water, Saccharin Sodium, Sodium Benzoate, Sorbitol.

Questions or Comments?

Call 1-800-527-5522

PACKAGE LABEL

Figure 1

H:\LABELING\Larken Labs (791043719)\SPL Only\EndaCof-DC OTC\spl\endacof-dc-label.jpg

ENDACOF  DC
codeine phosphate and pseudoephedrine hydrochloride   liquid
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)68047-148
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE PHOSPHATE (CODEINE) CODEINE PHOSPHATE10 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorFRUIT (GUM) Imprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
168047-148-16473 mL In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/19/2010

Labeler - Larken Laboratories, Inc. (791043719)
Registrant - Larken Laboratories, Inc. (791043719)
Establishment
NameAddressID/FEIOperations
Deltex Pharmaceuticals, Inc.019851778MANUFACTURE
Revised: 10/2010Larken Laboratories, Inc.