Label: LOHIST D- chlorpheniramine maleate / pseudoephedrine hcl liquid

  • NDC Code(s): 68047-120-16
  • Packager: Larken Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 12, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    (In each 5 mL teaspoonful)

    Chlorpheniramine Maleate, USP 2 mg

    Pseudoephedrine HCl, USP 30 mg

  • Purpose

    Chlorpheniramine Maleate Antihistamine

    Pseudoephedrine HCl Nasal decongestant

  • Uses

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

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • 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
  • 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.
    • symptoms do not improve within 7 days or are accompanied by fever.
  • 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 4 doses in a 24-hour period

    AgeDose
    Adults and children over 12 years of age2 teaspoonsful (10 mL) every 4 to 6 hours
    Children 6 to under 12 years of age1 teaspoonful (5 mL) every 4 to 6 hours
    Children under 6 years of ageAsk your doctor
  • Other information

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

    cherry flavoring, methylparaben, polyethylene glycol, propylparaben, purified water saccharin sodium, and sorbitol

  • 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.

  • Package Label, Principal Display Panel

    Figure 1: 16 oz. bottle label

    figure-01
  • INGREDIENTS AND APPEARANCE
    LOHIST  D
    chlorpheniramine maleate / pseudoephedrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68047-120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68047-120-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/15/2003
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/15/2003
    Labeler - Larken Laboratories, Inc. (149484540)
    Registrant - Larken Laboratories, Inc. (149484540)
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