Label: LOHIST DM- brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

  • NDC Code(s): 68047-129-16
  • Packager: Larken Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    (In each 5 mL teaspoonful)

    Brompheniramine Maleate, USP 2 mg

    Dextromethorphan HBr, USP 10 mg

    Phenylephrine HCl, USP 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, or associated with sinusitis.
    • 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

    AgeDose
    Adults and children over 12 years of age2 teaspoonsful (10 mL) every 4 hours
    Children 6 to under 12 years of age1 teaspoonful (5 mL) every 4 hours
    Children under 6 years of ageAsk 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 1-601-855-7678 weekdays from 9:00 am to 4:00 pm CST or go to http://www.larkenlabs.com.

  • Principal Display Panel

    16 oz Bottle Label

    PDP
    Drug Facts
  • INGREDIENTS AND APPEARANCE
    LOHIST DM 
    brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-129
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68047-129-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/01/2012
    Labeler - Larken Laboratories, Inc. (149484540)
    Registrant - Larken Laboratories, Inc. (149484540)
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