Label: PM PAIN RELIEVER- acetaminophen and diphenhydramine citrate tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 02/15

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

  • Active ingredients (in each tablet)

    Acetaminophen 500 mg
    Diphenhydramine citrate 38 mg

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  • Purpose

    Pain reliever
    Nighttime sleep-aid

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  • Uses

    for the 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 2 tablets in 24 hours, which is the maximum daily amount

    • with other drugs containing acetaminophen

    • 3 or more alcoholic drinks every day while using this product

    Do not use

    • if you are allergic to acetaminophen

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    • in children under 12 years of age

    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis

    • liver disease

    • glaucoma

    • trouble urinating due to an enlarged prostate gland

    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 may occur

    • avoid alcoholic beverages

    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

    • pain gets worse or lasts more than 10 days

    • fever gets worse or lasts more than 3 days

    • new symptoms occur

    • painful area is red or swollen

    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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    • do not take more than directed (see overdose warning)

    • adults and children 12 years of age and over: take 2 tablets at bedtime, if needed, or as directed by a doctor

    • children under 12 years: do not use

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  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

    • see end flap for expiration date and lot number

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  • Inactive ingredients

    corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, shellac, silica gel, stearic acid, titanium dioxide

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    RITE AID®
    PHARMACY                                                *Compare to the active ingredients in Excedrin® PM

    PM pain reliever
    acetaminophen
    500 mg
    diphenhydramine citrate 38 mg

    pain reliever • nighttime sleep aid

    aspirin free
    non-habit forming                     ACTUAL SIZE

    100COATED TABLETS

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

    *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excedrin® PM.

    50844        REV0414A37312

    DISTRIBUTED BY: RITE AID
    30 HUNTER LANE, CAMP HILL, PA 17011

    Rite Aid 44-373

    Rite Aid 44-373

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  • INGREDIENTS AND APPEARANCE
    PM PAIN RELIEVER 
    acetaminophen and diphenhydramine citrate tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0373
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE 38 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BLUE Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code 44;373
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0373-2 1 in 1 CARTON
    1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 06/07/2004
    Labeler - Rite Aid (014578892)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(11822-0373)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(11822-0373)
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