EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [SPIRIT PHARMACEUTICAL LLC]

EXTRA STRENGTH PAIN RELIEF PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [SPIRIT PHARMACEUTICAL LLC]
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NDC 68210-0099-2
Set ID e8f71439-5c07-44ab-9c4d-42ed41eb159a
Category HUMAN OTC DRUG LABEL
Packager Spirit Pharmaceutical LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • 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 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while you are 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 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 disease
    • breathing problems such as emphysema or chronic bronchitis
    • trouble 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 directed 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

    • do not take more than directed

    (see Overdose warning)

    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 of 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

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

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

  • Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:

    SPIRIT PHARMACEUTICALS, LLC.

    RONKONKOMA, NY 11779

  • Principal display panel

    VALUMEDS™

    SEE NEW WARNINGS INFORMATION

    Compare to the active ingredients in

    EXTRA STRENGTH TYLENOL®PM*

    EXTRA STRENGTH

    PAIN RELIEF PM

    PAIN RELIEVER NIGHTTIME SLEEP AID

    Acetaminophen 500 mg

    Diphenhydramine HCl 25 mg

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  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEF PM 
    acetaminophen and diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0099
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code S525
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0099-21 in 1 CARTON04/11/2018
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68210-0099-31 in 1 CARTON04/11/2018
    250 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:68210-0099-5375 in 1 PACKAGE; Type 0: Not a Combination Product03/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/10/2018
    Labeler - Spirit Pharmaceutical LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELYSIUM PHARMACEUTICALS LTD915664486manufacture(68210-0099)

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