ENDACOF DROPS  - chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride 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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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:

Warnings

Do not exceed recommended dosage.

Stop use and ask a doctor

Do not use

When using this product

Ask a doctor before use

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

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

4f94d4bc-figure-01

Figure 2: 2 oz. Carton

4f94d4bc-figure-02

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 DescriptionMultilevel Packaging
1NDC:68047-033-021 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
159.2 mL in 1 BOTTLEThis package is contained within the CARTON (68047-033-02)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/16/2011

Labeler - Larken Laboratories, Inc. (791043719)
Registrant - Larken Laboratories, Inc. (791043719)
Establishment
NameAddressID/FEIOperations
T.G. United830980947MANUFACTURE

Revised: 05/2011 Larken Laboratories, Inc.