Label: ALLERGY RELIEF- diphenhydramine hydrochloride capsule 

  • 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 09/13

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

  • Active ingredient (in each banded 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

      • itchy, watery eyes

      • sneezing 

      • 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

    • 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

    If pregnant of 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
    adults and children 12 years of age and over 1 to 2 capsules 
    children 6 to under 12 years of age 1 capsule 
    children under 6 years of age do not use this product in children under 6 years of age 
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

    • protect from moisture

    • see end flap for expiration date and lot number

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  • Inactive ingredients

    butylparaben, corn starch, D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, propylparaben, polysorbate 80, silica gel

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    FAMILY wellness

    COMPARE TO THE ACTIVE INGREDIENT OF BENADRYL®*

    Allergy Relief
    Diphenhydramine HCl 25 mg
    Antihistamine
    For Relief of: Runny Nose, Sneezing, Itchy Throat, Itchy, Watery Eyes

    100 CAPSULES

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl®.
    50844        REV0512A19012

    DISTRIBUTED BY:
    FAMILY DOLLAR SERVICES, INC.,
    10401 MONROE RD,
    MATTHEWS, NC 28105 USA

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING

    Family Wellness 44-190

    Family Wellness 44-190

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  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55319-190
    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
    BUTYLPARABEN  
    D&C RED NO. 28  
    FD&C BLUE NO. 1  
    GELATIN  
    LACTOSE  
    MAGNESIUM STEARATE  
    METHYLPARABEN  
    PROPYLPARABEN  
    POLYSORBATE 80  
    Product Characteristics
    Color PINK (pink, clear with a red band) Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code 44;107
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55319-190-12 1 in 1 CARTON
    1 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 03/15/1990
    Labeler - Family Dollar (024472631)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(55319-190)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(55319-190)
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