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Pill Identifier Information of Dextromethorphan Hydrobromide 15 MG Oral Capsule

Drug Information

Dextromethorphan Hydrobromide 15 MG Oral Capsule

Imprint:
Shape: C48345
Color: C48326
Ingredients: Dextromethorphan
Size: 15.00
Score: 1
Rxtty: SCD
Author: SPIRIT PHARMACEUTICALS,LLC
Inactive Ingredients: POLYETHYLENE GLYCOL 400 / PROPYLENE GLYCOL / GELATIN / POVIDONE / SORBITOL / WATER / GLYCERIN / FD&C RED NO. 40 / FD&C BLUE NO. 1>

Complete Information

  • 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)