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EndaCof DM (Larken Laboratories, Inc.)

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LIQUID 473 mL in 1 BOTTLE (68047-143-16) Label Information

Complete EndaCof DM Information

  • SPL UNCLASSIFIED SECTION

    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):

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

  • Warnings

    Do not use

    • to sedate a child or make a child sleepy
    • 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 drug.

  • Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
    • a cough that occurs with too much phlegm (mucus)

  • Ask a doctor or pharmacist before use if you are

    • taking any other nasal decongestant or stimulant
    • taking sedatives or tranquilizers

  • When using this product

    Do not exceed recommended dosage.

    • marked drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

  • Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur.
    • 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 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

    • store at 20°-25°C (68°-77°F)
    • very low sodium, contains 1 mg sodium per teaspoonful (5 mL)

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


  • Principal Display Panel

    Figure 1: 16 oz. Bottle Label

    figure-01

  • INGREDIENTS AND APPEARANCE
    ENDACOF DM 
    brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68047-143
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color red Score     
    Shape Size
    Flavor STRAWBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68047-143-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/30/2012
    Labeler - Larken Laboratories, Inc. (149484540)