Label: NOHIST DM- chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

  • NDC Code(s): 68047-186-16
  • Packager: Larken Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 12, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    (In each 5 mL teaspoonful)

    Chlorpheniramine Maleate, USP 4 mg

    Dextromethorphan HBr, USP 15 mg

    Phenylephrine HCl, USP 10 mg

  • Purpose

    Chlorpheniramine 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 two 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 age1 teaspoonsful (5 mL) every 4 hours
    Children 6 to under 12 years of age1/2 teaspoonsful (2.5 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 5 mg sodium per 5 mL teaspoonful
  • Inactive Ingredients

    citric acid, edetate disodium, glycerin, grape flavoring, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, and sodium citrate dihydrate

  • 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

    figure-01
  • INGREDIENTS AND APPEARANCE
    NOHIST DM 
    chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-186
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68047-186-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/06/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/06/2011
    Labeler - Larken Laboratories, Inc. (149484540)
    Registrant - Larken Laboratories, Inc. (149484540)