Label: SAFREL COUGH RELIEF- dextromethorphan hydrobromide capsule, liquid filled

  • NDC Code(s): 71309-601-10, 71309-601-30, 71309-601-60
  • Packager: Safrel Pharmaceuticals, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 January 1, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Dextromethorphan HBr, USP 15mg

  • 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 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 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 orcontact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    • do not take more than 8 capsules 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 overtake 2 capsules every 6 to 8 hours, as needed
    children under 12 yearsdo 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

    FD&C Red No. 40, gelatin, glycerin, polyethylene
    glycol 400, propylene glycol, povidone,
    sorbitol sorbitan solution, titanium dioxide

  • Questions or comments?

    1-844-384-3723

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Safrel Pharmaceuticals, LLC

    Bridgewater, NJ 08807

    www.safrel.com

  • PRINCIPAL DISPLAY PANEL

    Safrel Dextromethorphan Softgels 15 mg - 100 ct

    Dextro

  • INGREDIENTS AND APPEARANCE
    SAFREL COUGH RELIEF 
    dextromethorphan hydrobromide capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-601
    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)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code IS3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71309-601-3030 in 1 BOTTLE; Type 0: Not a Combination Product10/28/2022
    2NDC:71309-601-10100 in 1 BOTTLE; Type 0: Not a Combination Product10/28/2022
    3NDC:71309-601-6060 in 1 BOTTLE; Type 0: Not a Combination Product10/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/28/2022
    Labeler - Safrel Pharmaceuticals, LLC. (080566287)
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