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Headache Relief PM (WALGREEN CO.)

Available Formats

Dosage Form Package Information Links
TABLET 1 BOTTLE, PLASTIC in 1 CARTON (0363-0373-12) > 100 TABLET in 1 BOTTLE, PLASTIC Label Information

Complete Headache Relief PM Information

  • Active ingredients (in each tablet)

    Acetaminophen 500 mg
    Diphenhydramine citrate 38 mg


  • Purpose

    Pain reliever
    Nighttime sleep-aid


  • Uses

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


  • 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.


  • 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


  • Other information

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

    • see end flap for expiration date and lot number


  • 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


  • Questions or comments?

    1-800-426-9391


  • Principal Display Panel

    Well at
    Walgreens
    WALGREENS PHARMACIST RECOMMENDEDÇ‚

    NDC 0363-0373-12

    Headache
    Relief PM
    Acetaminophen
    / Pain Reliever
    Diphenhydramine Citrate / Nighttime Sleep Aid
    Aspirin free
    Non-habit forming

    100 COATED TABLETS

    NIGHTTIME

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

    Ç‚Walgreens Pharmacist Survey Study, November 2014.

    50844    REV0414B37312

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    Walgreens
    100% SATISFACTION GUARANTEED
    walgreens.com © 2015 Walgreen Co.

    Walgreens 44-373

    Walgreens 44-373


  • INGREDIENTS AND APPEARANCE
    HEADACHE RELIEF PM 
    acetaminophen, diphenhydramine citrate tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0373
    Route of Administration ORAL
    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)  
    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)  
    POVIDONE (UNII: FZ989GH94E)  
    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:0363-0373-12 1 in 1 CARTON 06/07/2004 05/13/2016
    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 05/13/2018
    Labeler - Walgreen Company (008965063)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(0363-0373)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(0363-0373)