Label: SLEEP AID MAXIMUM STRENGTH- diphenhydramine hydrochloride capsule 

  • NDC Code(s): 41520-231-32, 41520-231-40
  • Packager: Care One (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 12/12

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

  • Active ingredient (in each softgel)

    Diphenhydramine HCl 50 mg

    Purpose

    Nighttime sleep- aid

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  • Use

    • helps to reduce difficulty falling asleep
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  • Warnings

    Do not give to children under 12 years of age.

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  • Do not use this product

    • With other products containing diphenhydramine, even one used on skin.
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  • Ask a doctor before use if you have

    • emphysema
    • chronic bronchitis
    • glaucoma
    • difficulty in urination due to an enlargement of the prostate gland

    Ask doctor or pharmacist before use if you are now taking

    sedatives or tranquilizers
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  • When using this product

    avoid alcoholic beverages

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  • Stop use and ask a doctor if

    •  sleeplessness persists for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
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  • If pregnant or breast-feeding,

    ask a health professional before use.
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  • 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

    • adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by a doctor
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  • Other information

    • Store at controlled room temperature 15°-30°C (59°-86°F)
    • do not use if imprinted safety seal under cap is broken or missing
    • *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®

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  • Inactive ingredients

    edible white ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special. Close
  • Principal Display Panel

    Compare to the Active Ingredient in Maximum Strength Unisom SleepGels®*

    Maximum Strength

    Sleep- Aid

    Helps to reduce difficulty falling asleep

    Diphenhydramine HCl 50 mg

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Distributed by: American Sales Company

    4201 walden avenue, Lancaster, NY 14086

    www.care1.com

    © 2009 S&S BRANDS, INC.

    Quality guaranteed or your money back

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  • Product Label

    CareOne

    Diphenhydramine HCl 50 mg

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  • INGREDIENTS AND APPEARANCE
    SLEEP AID  MAXIMUM STRENGTH
    diphenhydramine hcl capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41520-231
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1  
    GELATIN  
    GLYCERIN  
    POLYETHYLENE GLYCOLS  
    WATER  
    SORBITOL  
    Product Characteristics
    Color BLUE Score no score
    Shape CAPSULE Size 13mm
    Flavor Imprint Code P50;A99
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-231-32 1 in 1 CARTON
    1 32 in 1 BOTTLE
    2 NDC:41520-231-40 1 in 1 BOX
    2 40 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/01/2010
    Labeler - Care One (American Sales Company) (809183973)
    Registrant - P and L Development of New York Corporation (800014821)
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