ENDACOF DM- brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid 
Larken Laboratories, Inc.

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EndaCof DM

Drug Facts

Active Ingredients

(In each 5 mL teaspoonful)

Brompheniramine Maleate, USP 1 mg

Dextromethorphan HBr, USP 5 mg

Phenylephrine HCl, USP 2.5 mg

Purpose

Brompheniramine Maleate Antihistamine

Dextromethorphan HBr Antitussive (cough suppressant)

Phenylephrine HCl Nasal decongestant

Uses

Temporarily relieves these symptoms due to hay fever (allergic rhinitis):

Warnings

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Do not exceed recommended dosage.

Stop use and ask a doctor if

If pregnant or breast-feeding

ask a health professional before use.

Keep out of the reach of children

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

Do not exceed 6 doses in a 24-hour period

Age Dose
Adults and children over 12 years of age:4 teaspoonsful (20 mL) every 4 hours
Children 6 to under 12 years of age:2 teaspoonsful (10 mL) every 4 hours
Children under 6 years of age:Ask your doctor

Other Information

Inactive Ingredients

Benzoic acid, edetate disodium, FD&C Red #40, propylene glycol, purified water saccharin sodium, sorbitol solution and strawberry flavoring

Questions or Comments

Call 1-601-855-7678 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com.

Principal Display Panel

Figure 1: 16 oz. Bottle Label (Front)

figure-01

Principal Display Panel

Figure 2: 16 oz. Bottle Label (Drug Facts Continued)

figure-02
ENDACOF DM 
brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-143
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68047-143-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/30/2012
Labeler - Larken Laboratories, Inc. (149484540)

Revised: 10/2023
Document Id: 078c3c82-b5fb-267f-e063-6294a90a14db
Set id: c68ea55a-8b9a-4a70-8b5c-1a2736651813
Version: 10
Effective Time: 20231012
 
Larken Laboratories, Inc.