Label: ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated

  • 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 November 18, 2021

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  • Drug Facts

    Active ingredients (in each caplet)

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

  • PURPOSE

    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 have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    ■ liver disease

    ■ a breathing problem such as emphysema or chronic bronchitis

    ■ difculty 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

    ■ avoid alcoholic beverages

    ■ do not drive a motor vehicle or operate machinery

    ■ drowsiness will occur

    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: 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 and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. ■ children under 12 years: do not use

  • Other information

    ■ store at room temperature

  • INACTIVE INGREDIENT

    croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide and triacetin

  • Questions or comments?

    Call (800) 616-2471

  • SPL UNCLASSIFIED SECTION

    KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

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

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

    Distributed by:

    MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

  • PRINCIPAL DISPLAY PANEL

    See New Warnings Information and Directions

    NDC 0904-6731-51

    MAJOR

    Extra Strength Acetaminophen PM Caplets

    Pain Reliever

    Sleep Aid

    Acetaminophen 500 mg and Diphenhydramine HCl 25 mg each

    Compare to active ingredient oin Extra Strength TYLENOL PM*

    50 Caplets

    Major Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE 
    acetaminophen, diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6731
    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
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TRIACETIN (UNII: XHX3C3X673)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code CPC752
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6731-511 in 1 CARTON12/26/2018
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/26/2018
    Labeler - Major Pharmaceuticals (191427277)
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