Label: PAIN RELIEF PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 May 31, 2016

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

    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.

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  • 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
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  • 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
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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 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.
    50844      REV0615B55609    1509

    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.

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

    H.E.B 44-556

    H.E.B 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
    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 (light and dark blue with gray in the middle) 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
    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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