Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hcl tablet, chewable

  • NDC Code(s): 49035-599-09, 49035-599-44
  • Packager: Wal-Mart Stores Inc
  • 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 August 8, 2017

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

  • Active ingredient (in each chewable tablet)

    Diphenhydramine HCl 12.5 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
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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

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • 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
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • use caution 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 (1-800-222-1222) right away.

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  • Directions

    • find right dose on chart below
    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 times in 24 hours
    Age (yr)
    Dose (chewable tablets)
    children under 2 years
     do not use
    children 2 to 5 years
    do not use unless directed by a doctor
    children 6 to 11 years
    1 to 2 chewable tablets (12.5 mg to 25 mg)
    adults and children 12 years and over 2 to 4 chewable tablets (25 mg to 50 mg)
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  • Other information

    • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid high humidity
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

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  • Questions or comments?

    1-888-287-1915

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  • Principal Display Panel

    NDC 49035-599-09

    equate™

    Compare
    to Children's
    Benadryl®
    Chewables Active
    Ingredient*


    Children's
    ALLERGY RELIEF

    Diphenhydramine HCl, 12.5 mg
    Antihistamine

    6 YEARS AND OLDER

    Relief of:
    • Sneezing         • Runny nose  
    • Itchy throat or nose
    • Itchy, watery eyes

    Cherry Flavored

    20 CHEWABLE TABLETS

    Actual Size

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

    *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Children’s Benadryl® Chewables.
    50844                ORG031759909

    Satisfaction guaranteed - Or we'll replace it or
    give you your money back. For questions or
    comments or to report an undesired reaction
    or side effect, please call 1-888-287-1915.

    Equate 44-599

    Equate 44-599

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  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    diphenhydramine hcl tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-599
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    DEXTRATES (UNII: G263MI44RU)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 12mm
    Flavor CHERRY Imprint Code 44;599
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-599-44 3 in 1 CARTON 04/25/2011
    1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:49035-599-09 4 in 1 CARTON 04/25/2011
    2 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 04/25/2011
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(49035-599)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(49035-599)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(49035-599)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(49035-599)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(49035-599)
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