Label: ALLERGY RELIEF- diphenhydramine hydrochloride capsule, liquid filled

  • NDC Code(s): 51013-108-02
  • Packager: PuraCap Pharmaceutical 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 June 27, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

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

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

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

    When using this product

    • avoid alcoholic beverages and other drugs that cause drowsiness
    • drowsiness will occur
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning

    Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take every 4 to 6 hours
    • do not take more than 6 doses in 24 hours
    adults and children 12 years of age and overtake 1 to 2 softgels 
    children 6 to under 12 years of agetake 1 softgel
    children under 6 years of age do not take this product in children under 6 years of age 

  • Other information

    • store at room temperature 15°-30° C (59°-86° F) in a dry place
    • protect from heat, humidity, and light
  • Inactive ingredients

    gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, and white edible ink

  • Questions or comments?

    Call toll free: 1-855-215-8180

  • PRINCIPAL DISPLAY PANEL - Carton Label

    PuraVation Allergy Relief 

    Diphenhydramine HCl - 25 mg EACH

    12 LIQUID-FILLED SOFTGELS

    NDC 51013-108-02

    Carton Label

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-108
    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
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Coloryellow (clear) Scoreno score
    Shapecapsule (oblong) Size15mm
    FlavorImprint Code PC4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51013-108-021 in 1 CARTON05/12/2014
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/12/2014
    Labeler - PuraCap Pharmaceutical LLC (962106329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd421293287manufacture(51013-108) , analysis(51013-108)
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