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Pain Reliever PM Extra Strength (H E B)

Available Formats

Dosage Form Package Information Links
CAPSULE 1 BOTTLE, PLASTIC in 1 CARTON (37808-556-09) > 20 CAPSULE in 1 BOTTLE, PLASTIC Label Information

Complete Pain Reliever PM Extra Strength Information

  • Active ingredients (in each gelcap)

    Acetaminophen 500 mg
    Diphenhydramine HCl 25 mg


  • Purpose

    Pain reliever
    Nighttime sleep-aid


  • Uses

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

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

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

    Ask a doctor before use if you have
    • a breathing problem such as emphysema or chronic bronchitis
    • liver disease
    • difficulty in urination due to enlargement of the 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 beverages
    • 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 a 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.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
    • adults and children 12 years and over
      • take 2 gelcaps at bedtime
      • do not take more than 2 gelcaps of this product in 24 hours
    • children under 12 years: do not use

  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid high humidity
    • see end flap for expiration date and lot number

  • Inactive ingredients

    ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide


  • Questions or comments?

    1-800-426-9391


  • Principal Display Panel

    Compare to Tylenol® PM Extra Strength active ingredients*

    NDC 37808-556-09

    HEB ®

    Extra Strength

    PAIN RELIEF
    PM

    Acetaminophen, 500 mg
    Diphenhydramine HCl, 25 mg
    Pain Reliever/Nighttime Sleep-Aid

    Rapid Release 

    Non-Habit Forming

    actual size

    20 GELCAPS

    *This product is not manufactured or distributed by Johnson
    & Johnson Corporation, owner of the registered trademark
    Tylenol® PM Extra Strength.
    50844      ORG041755609   

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

    MADE WITH PRIDE AND CARE FOR
    H-E-B®, SAN ANTONIO, TX 78204

    100%
    GUARANTEE
    promise

    If you aren't completely
    pleased with this product,
    we'll be happy to replace
    it or refund your money.
    You have our word on it.

    HEB 44-556

    HEB 44-556


  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PM  EXTRA STRENGTH
    acetaminophen, diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-556
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SHELLAC (UNII: 46N107B71O)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Color BLUE (Light) , BLUE (Dark) Score no score
    Shape OVAL Size 20mm
    Flavor Imprint Code L;6
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-556-09 1 in 1 CARTON 12/17/2007
    1 20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:37808-556-31 80 in 1 BOTTLE; Type 0: Not a Combination Product 12/17/2007
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 12/17/2007
    Labeler - H E B (007924756)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(37808-556)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 MANUFACTURE(37808-556) , PACK(37808-556)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(37808-556)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(37808-556)