Label: PAIN RELIEF PM EXTRA STRENGTH- acetaminophen and diphenhydramine hydrochloride tablet

  • 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 12/15

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

  • Active ingredients (in each gelcap)

    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
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product 
    • in children under 12 years of age

    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

    • avoid alcoholic beverages
    • drowsiness will occur
    • 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.

    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 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
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  • Other information

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

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    Compare to Extra Strength Tylenol® PM Rapid Release Gels active ingredients*

    NDC 37808-556-09

    H•E•B ®

    P A I N   R E L I E F   P M
    Extra Strength    •    Rapid Release
    Acetaminophen, Diphenhydramine HCl

    Pain Reliever/Nighttime Sleep-Aid
    Non-Habit Forming

    ACTUAL SIZE

    20 Gelcaps

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM Rapid Release Gels.
    50844      REV0413A55609    1306

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

    GUARANTEE
    We believe the high quality of this H-E-B product makes it an outstanding value. We hope you'll agree.  If not, we'll cheerfully refund your money. Thanks for shopping with us.     

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

    HEB 44-556

    HEB 44-556

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  • 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 DEA Schedule     
    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)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL Size 21mm
    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
    1 20 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 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. 832867894 MANUFACTURE(37808-556)
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