Label: ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

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 December 27, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purpose
    Acetaminophen 500mgPain reliever
    Diphenhydramine HCl 25mgNighttime 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 with this product if you take

    • more than 2 caplets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while you are using this product

    Do not use

    • with other products 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 products containing diphenhydramine, even one used on skin
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if you have

    • liver cirrhosis
    • asthma
    • breathing problems such as emphysema or chronic bronchitis
    • trouble in urinating due to an 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 drinks
    • 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
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    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 right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    adults and children 12 years of age and over:
    • take 2 caplets at bedtime or as directed by a doctor
    • do not take more than 2 caplets in a 24 hour period
    children under 12 years or age:
    • do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage
  • Other information

    • store at 20°-25°C (68°-77°F)
    • see end panel for lot number and expiration
    • each tablet contains: magnesium 0.05 mg
  • Inactive ingredients

    FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, pregelatinized starch, povidone, stearic acid, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    Distributed By: J.P Business Enterprise Lake Grove, NY 11755

  • PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

    VALUMEDS

    SEE NEW WARNINGS INFORMATION

    Compare to the active ingredients
    in TYLENOL ® PM *

    EXTRA STRENGTH

    PAIN RELIEF PM

    PAIN RELIEVER • NIGHTTIME SLEEP AID

    Acetaminophen 500 mg
    Diphenhydramine HCl 25 mg

    24 CAPLETS

    Principal Display Panel - 24 Caplet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE 
    acetaminophen and diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59105-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code S525
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59105-001-241 in 1 CARTON08/20/2013
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/20/2013
    Labeler - J.P. BUSINESS ENTERPRISE (078775890)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELYSIUM PHARMACEUTICALS LTD915664486manufacture(59105-001)
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