Label: AXIM ALLERGY- diphenhydramine hydrochloride capsule, liquid filled

  • NDC Code(s): 82706-005-01, 82706-005-02
  • Packager: VIVUNT 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 September 20, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient (in each softgel)Purpose
    Diphenhydramine HCl 25 mgAntihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
  • Warnings

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Keep out of reach of children.

    If pregnant or breast-feeding

    ask a health professional before use.

    Overdose Warning

    In case of overdose, get medical help or contact a poison control center immediately.

  • Directions

    • Take every 4 to 6 hours, or as directed by a doctor
    • Do not take more than 12 Softgels in 24 hours for Adults and do not take more than 6 Softgels for children 6 to 12 years of age in 24 hours.

    adults and children 12 years and over 1 or 2 Softgels
    children 6 to under 12 years1 Softgel
    children under 6 yearsdo not use
  • Other information

    • Store at 20° - 25 °C (68 °- 77 °F)
    • Read all product information before using
    • Tamper Evident: Do not use if the foil printed on the blister is torn or ripped.
  • Inactive ingredients

    Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide

  • PRINCIPAL DISPLAY PANEL 24

    Compare to Benadryl® Allergy Liqui-Gels®

    active ingredients*

    NDC 82706-005-01

    Antihistamine

    • Runny Nose
    • Sneezing
    • Itchy, Watery Eyes
    • Itchy Throat

    DYE-FREE

    Diphenhydramine HCl

    24 SOFTGELS** **Liquid-filled capsules

    Axim Allergy

  • PRINCIPAL DISPLAY PANEL 6

    Compare to Benadryl® Allergy Liqui-Gels®

    active ingredients*

    NDC 82706-005-02

    Antihistamine

    Runny Nose
    Sneezing
    Itchy, Watery Eyes
    Itchy Throat

    DYE-FREE

    Diphenhydramine HCl

    6 SOFTGELS** **Liquid-filled capsules

    Allergy

  • INGREDIENTS AND APPEARANCE
    AXIM ALLERGY 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82706-005
    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
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GELATIN (UNII: 2G86QN327L)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (Transparent) Scoreno score
    ShapeOVALSize22mm
    FlavorImprint Code axim
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82706-005-012 in 1 CARTON05/09/2022
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:82706-005-023 in 1 CARTON09/20/2023
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/09/2022
    Labeler - VIVUNT LLC (045829437)