Label: LONG ACTING TUSSIN COUGH GELS- dextromethorphan hydrobromide capsule, gelatin coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/13

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

  • Active ingredient (in each liquidgel)

    Dextromethorphan HBr, USP 15 mg 

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  • Purpose

    Cough suppressant 

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  • Use

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

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  • 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 as occurs with smoking, asthma, or emphysema 

    Stop use and ask a doctor if

    cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or presistent headache. These could be signs of a serious condition.  

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

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  • Directions

    • do not take more than 8 liquidgels in any 24-hour period
    • adults and children 12 years and over: take 2 liquidgels every 6 to 8 hours, as needed 
    • children under 12 years: do not use
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  • Other information

    • store at 20º-25ºC (68º-77ºF)
    • avoid excessive heat above 40ºC (104ºF)
    • protect from light
    • use by expiration date on package
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  • Inactive ingredients

    FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, white edible ink 

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  • Principal display panel

    RITE AID®
    PHARMACY

    *Compare to the active ingredient in Robitussin® CoughGels®

    LONG-ACTING
    tussin
    cough relief gels
    dextromethorphan HBr 15 mg
    cough suppressant

    NON-DROWSY
    relieves coughs for up to 8 hours

    12 years & older

    liquid-filled capsules you just swallow

    non-narcotic formula

    20 LIQUIDGELS
    (LIQUID FILLED CAPSULES)

    *This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Robitussin® CoughGels®.

    50844        REV0512A44209

    DISTRIBUTED BY:
    RITE AID
    30 HUNTER LANE
    CAMP HILL, PA
    17011

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Rite Aid 44-442

    Rite Aid 44-442

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  • INGREDIENTS AND APPEARANCE
    LONG ACTING TUSSIN COUGH GELS 
    dextromethorphan hbr capsule, gelatin coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0442
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    WATER  
    SORBITOL  
    Product Characteristics
    Color RED Score no score
    Shape CAPSULE Size 13mm
    Flavor Imprint Code 033
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0442-9 1 in 1 PACKAGE
    1 20 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 04/24/2006
    Labeler - Rite Aid (014578892)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(11822-0442)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(11822-0442)
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