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EndaCof Drops

Dosage form: liquid
Ingredients: CHLORPHENIRAMINE MALEATE 1mg in 1mL, DEXTROMETHORPHAN HYDROBROMIDE 2.5mg in 1mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1mL
Labeler: Larken Laboratories, Inc.
NDC Code: 68047-033

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 Drops

Drug Facts

Active Ingredients

(per 1 mL)

Chlorpheniramine Maleate 1 mg

Dextromethorphan Hydrobromide 2.5mg

Phenylephrine Hydrochloride 2.5mg

Purpose

Chlorpheniramine Maleate Antihistamine

Dextromethorphan HBr Cough Suppressant

Phenylephrine HCl Decongestant

Uses

Temporarily relieves:

  • runny nose
  • reduces sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever or other respiratory allergies
  • nasal congestion due to the common cold
  • cough due to minor throat and bronchial irritation associated with the common cold
  • temporarily restores free breathing through the nose

Warnings

Do not exceed recommended dosage.

Stop use and ask a doctor
  • If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.
  • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

Do not use
  • this product for a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.
  • this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • A persistent cough may be a sign of a serious condition.
  • If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
  • in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

When using this product
  • May cause excitability especially in children.
  • May cause marked drowsiness.

Ask a doctor before use
  • for children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.

Keep out of the reach of children

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Directions

2-6 years: = (1 mL) every 4 to 6 hours

6-12 years: = (2 mL) every 4 to 6 hours

  • Do not exceed 4 doses during a 24-hour period or as directed by a Doctor

Other Information
  • Store at controlled room temperature 20°- 25°C (68°- 77°F)

Inactive Ingredients

Citric Acid, Glycerin, Grape flavor, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose

Questions or Comments

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

Principal Display Panel

Figure 1: 2 oz. Bottle Label

Figure 2: 2 oz. Carton

ENDACOF DROPS 
chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-033
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE1 mg  in 1 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE2.5 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
METHYLPARABEN 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLPARABEN 
PROPYLENE GLYCOL 
WATER 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68047-033-021 BOTTLE (BOTTLE) in 1 CARTON
159.2 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/16/201104/30/2013
Labeler - Larken Laboratories, Inc. (791043719)
Registrant - Larken Laboratories, Inc. (791043719)
Establishment
NameAddressID/FEIOperations
T.G. United830980947MANUFACTURE

Revised: 05/2011
 
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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