Label: ALLERGY RELIEF ANTIHISTAMINE- diphenhydramine hydrochloride capsule, liquid filled 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

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

  • Active ingredient (in each capsule)

    Diphenhydramine HCl 25 mg

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  • Purpose

    Antihistamine

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  • 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 
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  • Warnings

    Do not use

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

    Ask a doctor before use if you have

    • glaucoma

    • trouble urinating due to an 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

    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

    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.

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  • Directions

    • take every 4 to 6 hours
    • do not take more than 6 doses in 24 hours
    • swallow whole; do not crush, chew or dissolve
    adults and children 12 years of age and over  take 1 or 2 capsules 
    children 6 to under 12 years of age  take 1 capsule
    children under 6 years of age  do not use
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  • Other information

    • store at 59° to 77°F in a dry place. Protect from heat, humidity and light
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  • Inactive ingredients

    edible dye free ink, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution.

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  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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  • Principal Display Panel

    *Compare to the Active Ingredient of Benadryl® Liqui-Gels®

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl®, or Catalent Pharma solutions, Inc., owner of the registered trademark Liqui-Gels®.

    Dye- Free

    Allergy Relief

    Diphenhydramine HCl 25 mg/ Antihistamine

    Relieves:

    • sneezing
    • runny nose
    • itchy, watery eyes
    • itchy nose or throat

    Softgels**

    (**Liquid-Filled Capsules)

    PRODUCT OF CANADA

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

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  • Product Label

    Freds Inc

    Diphenhydramine HCl 25 mg capsules

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  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF  ANTIHISTAMINE
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55315-721
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN  
    GLYCERIN  
    POLYETHYLENE GLYCOLS  
    WATER  
    SORBITOL  
    SORBITAN  
    Product Characteristics
    Color WHITE, YELLOW Score no score
    Shape CAPSULE Size 15mm
    Flavor Imprint Code A33
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55315-721-24 2 in 1 CARTON
    1 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 04/08/2013
    Labeler - Freds Inc (005866116)
    Registrant - P and L Development of New York Corporation (800014821)
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