Label: CAREONE ALLERGY MEDICATION- diphenhydramine hydrochloride tablet 

  • Label RSS
  • NDC Code(s): 41520-361-62, 41520-361-68, 41520-361-78
  • Packager: American Sales Company
  • 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 08/13

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

  • Active ingredient (in each tablet)

    Diphenhydramine hydrochloride 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
    itchy nose or throat
    temporarily relieves these symptoms of 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
    excitability may occur, especially in children
    alcohol, sedatives and tranquilizers may increase drowsiness
    be careful when driving a motor vehicle or operating machinery

    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, not more than 6 doses in 24 hours

    adults and children 12 years of age and over

    1 or 2 tablets

    children 6 to under 12 years of age

    1 tablet

    children 4 to under 6 years of age

    do not use unless directed by a doctor

    children under 4 years of age

    do not use

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  • Other information

    each tablet contains: calcium 20 mg
    store at 20°-25°C
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  • Inactive ingredients

    carnauba wax, crospovidone, D&C red no. 27 aluminum lake, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to the Active Ingredient in Benadryl® Allergy Ultratab®

    ALLERGY MEDICATION

    Small Tablet Size

    Diphenhydramine Hydrochloride 25 mg – Antihistamine

    EASY TO SWALLOW

    For Allergy Relief

    Sneezing – Itchy, Watery Eyes

    Runny Nose – Itchy Throat

    100 TABLETS

    American Sales Company Allergy Medication.jpg
    American Sales Company Allergy Medication.jpg
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  • INGREDIENTS AND APPEARANCE
    CAREONE ALLERGY MEDICATION 
    diphenhydramine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-361
    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
    CARNAUBA WAX  
    CROSPOVIDONE  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POLYSORBATE 80  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    Product Characteristics
    Color PINK (dark) Score no score
    Shape CAPSULE Size 10mm
    Flavor Imprint Code L479
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-361-62 2 in 1 CARTON
    1 12 in 1 BLISTER PACK
    2 NDC:41520-361-68 3 in 1 CARTON
    2 12 in 1 BLISTER PACK
    3 NDC:41520-361-78 1 in 1 CARTON
    3 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 05/24/2004
    Labeler - American Sales Company (809183973)
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