Label: RIGHT REMEDIES ADULT LONG LASTING COUGH RELIEF SOFTGEL- dextromethorphan hydrobromide capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 29, 2023

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  • Drug Facts

  • Active ingredient (in each softgel)

    Dextromethorphan HBr, USP 15 mg

  • Purpose

    Cough Suppressant

  • Use

    temporarily relieves cough due to minor throat and bronchial irritation as 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 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 persistent headache. These can be signs of a serious condition.

    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 (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than 8 softgels in any 24-hour period
    • this adult product is not intended for use in children under 12 years of age

    adults and children
    12 years and older    		take 2 softgels
    every 6 to 8
    hours, as needed
    children under
    12 years    		 do not use

  • Other information

    • store at 20°-25°C(68°-77°F)
    • avoid excessive heat above 40°C(104°F)
    • protect from light

  • Inactive ingredients

    edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propyl gallate, propylene glycol, purified water, sorbitol sorbitan solution

  • Questions or comments?

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    Monday - Friday 8am - 4pm EST

  • SPL UNCLASSIFIED SECTION

    Compare to the active ingredient of ROBITUSSIN® CoughGels®*

    Relieves:
    Cough for up to 8 hours
    Non-Drowsy

    ages 12+

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

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

    Distributed by:
    Strive Pharmaceuticals Inc.
    East Brunswick, NJ 08816

    Product of UAE

    Packaged and Quality Assured in the USA

  • Packaging

    Strive-778

  • INGREDIENTS AND APPEARANCE
    RIGHT REMEDIES ADULT LONG LASTING COUGH RELIEF SOFTGEL 
    dextromethorphan hydrobromide capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-778(NDC:73056-019)
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVAL (oblong) Size14mm
    FlavorImprint Code 778
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-778-0660 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/01/2022
    Labeler - Strive Pharmaceuticals Inc. (080028013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Strive Pharmaceuticals Inc.080028013repack(70692-778)
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