EndaCof DC

Dosage form: liquid
Ingredients: CODEINE PHOSPHATE 10mg in 5mL, PSEUDOEPHEDRINE HYDROCHLORIDE 30mg in 5mL
Labeler: Larken Laboratories, Inc.
NDC Code: 68047-148

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.

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
relieves sinus congestion and pressure.

Warnings

Do not exceed recommended dosage.

may cause aggravated constipation
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

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.

Do not take this product, unless directed by a doctor before use if you have
a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a cough that occurs with too much phlegm (mucus)
heart disease, diabetes, high blood pressure or thyroid disease
difficulty in urination due to enlargement of the prostate gland.

Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occurs
symptoms do not improve within 7 days or are accompanied by a fever
cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache; these could be signs of a serious condition.

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

Bubblegum flavor, Citric Acid, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl

Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose, Tutti-Frutti flavor

Questions or Comments?

Call 1-800-527-5522

PACKAGE LABEL

Figure 1: 16 oz. container label

ENDACOF  DC
codeine phosphate and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-148
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CODEINE PHOSPHATE (CODEINE ANHYDROUS) CODEINE PHOSPHATE10 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
METHYLPARABEN 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLPARABEN 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorTUTTI FRUTTI ( BUBBLEGUM) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68047-148-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/19/201002/28/2013
Labeler - Larken Laboratories, Inc. (791043719)
Registrant - Larken Laboratories, Inc. (791043719)
Establishment
NameAddressID/FEIOperations
TG United Liquid, Inc.830980947MANUFACTURE

Revised: 04/2012
 
Larken Laboratories, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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