Label: SLEEP AID MAXIMUM STRENGTH- diphenhydramine hydrochloride capsule 

  • Label RSS
  • NDC Code(s): 49348-074-03, 49348-074-06
  • Packager: Mckesson (Sunmark)
  • 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 09/12

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 maximum strength unisom sleepgels® active ingredient*

    Sleep aid

    Maximum strength

    Diphenhydramine Hydrochloride

    Easy to swallow

    Another quality product distributed by McKesson

    one post street,

    San Francisco, CA 94104

    Money back gurantee

    Please visit us at www.sunmarkbrand.com

    Questions or comments? Call toll free: 1-877-753-3935 

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  • Product Label

    Sunmark sleep aid

    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:49348-074
    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:49348-074-03 2 in 1 CARTON
    1 8 in 1 BLISTER PACK
    2 NDC:49348-074-06 1 in 1 CARTON
    2 32 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/09/2010
    Labeler - Mckesson (Sunmark) (177667227)
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