Label: NON ASPIRIN PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride tablet, coated 

  • Label RSS
  • NDC Code(s): 55315-360-10, 55315-360-50
  • Packager: Freds Inc
  • 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 ingredients (in each geltab)

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

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  • Purpose

    Pain reliever

    Nighttime sleep-aid

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  • Uses

    temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours 
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • with any other product containing diphenhydramine, even one used on skin
    • in children under 12 years of age

    Ask a doctor before use if you have

    • liver disease
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland
    • glaucoma

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product

    • drowsiness will occur
    • avoid alcoholic drinks
    • do not drive a motor vehicle or operate machinery

    Stop use and ask a doctor if

    • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
    • new symptoms occur
    • redness or swelling is present
    • pain gets worse or lasts more than 10 days 
    • fever gets worse or lasts more than 3 days

    These could be signs of a serious condition

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Directions

    • do not take more than directed (see overdose warning)
    • adults and children 12 years and over: take 2 geltabs at bedtime. Do not take more than 2 geltabs of this product in 24 hours.
    • children under 12 years: do not use

    Other information

    • store at room temperature 15o- 30o C (59o- 86o F)
    • avoid high humidity and excessive heat
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  • Inactive ingredients

    corn starch*, croscarmellose sodium*, D&C red #27 aluminum lake, edible black ink, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose*, maltodextrin*, microcrystalline cellulose*, polyethylene glycol*, povidone*, purified water, silicon dioxide*, stearic acid, titanium dioxide
    *contains one or more of these ingredients

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  • Questions or comments?

    Call toll free 1-877-753-3935 Monday- Friday 9AM- 5PM EST

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  • Principal Display Panel

    Compare to the active ingredients in extra strength TYLENOL® PM **

    NON-ASPIRIN PM

    extra strength

    ACETAMINOPHEN 500 mg

    DIPHENHYDRAMINE HCl 25 mg

    pain reliever/ nighttime sleep-aid

    ** This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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  • Product Label

    Freds Inc Non aspirin geltabs

    Non-Aspirin PM Geltabs

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  • INGREDIENTS AND APPEARANCE
    NON ASPIRIN PM  EXTRA STRENGTH
    acetaminophen, diphenhydramine hcl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55315-360
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    CROSCARMELLOSE SODIUM  
    D&C RED NO. 27  
    FD&C BLUE NO. 1  
    GELATIN  
    GLYCERIN  
    HYPROMELLOSES  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    POVIDONES  
    WATER  
    SILICON DIOXIDE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    ALUMINUM OXIDE  
    Product Characteristics
    Color BLUE, WHITE Score no score
    Shape ROUND Size 13mm
    Flavor Imprint Code BPI50
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55315-360-10 1 in 1 CARTON
    1 100 in 1 BOTTLE
    2 NDC:55315-360-50 1 in 1 CARTON
    2 50 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part338 11/30/2012
    Labeler - Freds Inc (005866116)
    Registrant - P and L Development of New York Corporation (800014821)
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