Label: DEXTROMETHORPHAN HYDROBROMIDE capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 26, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each LiquiCap)

    Dextromethorphan Hbr 15 mg

  • Purpose

    Cough Suppressant

  • Uses temporarily

    relieves cough due to minor throat and bronchial irritation may occur with a cold

  • Warnings

    Do not use

    *
    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 product.

    Ask a doctor before use if you have

    *
    a cough that occurs with too much phlegm(mucus)
    *
    a cough that lasts or is chronic cough as occurs with smoking, asthma or emphysema

    Stop use and ask doctor if

    *
    cough lasts for more than 7 days,comes back or is accompanied by fever, rash, or persistent headache

    These could be signs of a serious conditions

    If pregnant or breast-feeding, ask a health professional before use

    Keep out of reach of children.

    Overdose Warning

    In case of overdose,get medical help or contact a poison control center right away.

  • Direction

    *
    do not take more than 8 liquidgels in any 24 hour period.
    *
    adults and children 12 years over : take 2 liquidgels every 6 to 8 hours, as needed
    *
    Children under 12years: ask a doctor
  • Other information

    *
    each tablet contains : Store at room temperature
  • Inactive ingredients

    FD &C Red No 40 IH, Polyethylene Glycol , Gelatin, Glycerin, Povidone, Purified water, Sorbitol

  • PRINCIPAL DISPLAY PANEL - 15mg Tablet Shipper Label

    Dextromethorphan Hydrobromide Soft Gelatin Capsules
    Each Soft Gelatin Capsules Contains:
    Dextromethorphan Hydrobromide USP 15mg

    Lot No. :

    Mfg. Date :

    Exp. Date :

    NDC No. : 68210-1530-4

    Quantity : 4000 Capsules

    Gross Wt. :

    WARNING :
    KEEP OUT OF THE REACH OF CHILDREN

    STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING

    THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
    CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
    CONFORMANCE WITH THE FDAAND REGULATIONS THEREUNDER

    MANUFACTURED BY:
    Marksans Pharma Ltd
    Verna, GOA-403722,
    India.
    Code : GO/DRUGS/515

    MANUFACTURED FOR:
    SPIRIT PHARMACEUTICALS,LLC
    225 LINCOLN HWY, STE # 205
    FAIRLESS HILLS, PA 19030
    PH.# 215 943 4000; FAX.#2159434039

    OMIL059

    CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

    PRINCIPAL DISPLAY PANEL - 15mg Tablet Shipper Label
  • INGREDIENTS AND APPEARANCE
    DEXTROMETHORPHAN HYDROBROMIDE 
    dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1530
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-1530-41 in 1 DRUM
    14000 in 1 BAG
    2NDC:68210-1530-61 in 1 DRUM
    26000 in 1 BAG
    3NDC:68210-1530-81 in 1 DRUM
    38000 in 1 BAG
    4NDC:68210-1530-11 in 1 DRUM
    410000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/15/2010
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
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