Label: BONINE FASTER-ACTING- diphenhydramine hcl tablet

  • NDC Code(s): 65197-616-16
  • Packager: WellSpring Pharmaceutical Corporation
  • 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 July 6, 2022

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  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antiemetic

  • Uses

    for prevention and treatment of nausea, vomiting, Uses or dizziness associated with motion sickness

  • Warnings

    Do not use

    ■ for children under 6 years of age unless

    ■ Do not use with any other product containing diphenhydramine, including one used on skin

    Ask a doctor before use if you have

    ■ difficulty in urination due to enlargement of the prostate gland

    ■ glaucoma

    ■ difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    ■ marked drowsiness may occur

    ■ alcohol, sedatives, and tranquilizers may increase drowsiness

    ■ avoid alcoholic beverages

    ■ use caution when driving a motor vehicle or operating machinery

    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 right away.

  • Directions

    ■ dosage should be taken 30 minutes before you begin motion activity.

    ■ adults and children 12 years and over: take 1 to 2 tablets with Water every 4 to 6 hours, not to exceed 12 tablets (300 milligrams) in 24 hours, or as directed by a doctor.

    ■ Children 6 to under 12 years of age: take 1 tablet with Water every 4 to 6 hours, not to exceed 6 tablets (150 milligrams) in 24 hours, or as directed by a doctor.

  • Other information

    ■ Each tablet contains: Calcium 60mg 

    ■ Store at 25°C (77°F); excursions permitted between 15° - 30°C (59° - 86°F)

    ■ protect from moisture

    ■ see end flap for expiration date and lot number

  • Inactive ingredients

    Croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1, aluminum lake, magnesium stearate, microcrystalline cellulose, silicone dioxide, stearic acid

  • Questions?

    1-844-241-5454 or www.bonine.com

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN. Keep Carton for important drug facts information.

    Distributed by: WellSpring
    Pharmaceutical Corporation
    Sarasota, FL 34243
    ©2023 WellSpring
    Pharmaceutical Corporation

    Money Back Guarantee

  • PRINCIPAL DISPLAY PANEL 65197-616-16

    NEW

    9X the Adventure**

    Diphenhydramine HCl - Antiemetic 25 mg

    Prevents & Treats:

    Vomiting  •  Nausea  •  Dizziness • Motion Sickness

    *See back panel reference

    * Than Meclizine HCL 25 mg per onset of action from The U.S. National Library of Medicine (NLM)

    ** Results may vary

    FASTER-ACTING* RELIEF

    TAKE WITH WATER

    Bonine Faster Acting IFC

    Bonine Faster Acting 2.0

  • INGREDIENTS AND APPEARANCE
    BONINE  FASTER-ACTING
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-616
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code WS1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65197-616-162 in 1 BOX05/01/2023
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33605/01/2023
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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