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Unisom PM Pain Nighttime Sleep Aid and Pain Reliever (Chattem, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 1 BOTTLE in 1 CARTON (41167-0040-2) > 15 TABLET in 1 BOTTLE Label Information
TABLET 1 BOTTLE in 1 CARTON (41167-0040-4) > 30 TABLET in 1 BOTTLE Label Information
TABLET 1 BOTTLE in 1 CARTON (41167-0040-3) > 20 TABLET in 1 BOTTLE Label Information

Complete Unisom PM Pain Nighttime Sleep Aid and Pain Reliever Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredients

    (in each caplet)

    Acetaminophen 325 mg


  • Purposes

    Pain reliever


  • Active ingredients

    (in each caplet)

    Diphenhydramine HCl 50 mg


  • Purposes

    Nighttime 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 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.
    • in children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin
    • 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
    • trouble urinating due to an enlarged 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 serious medical illness.
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • redness or swelling is present
    • new symptoms occur

    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. 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 older: take 1 caplet at bedtime

    do not take more than 1 caplet of this product in 24 hours

    children under 12 years: 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


  • Inactive ingredients

    blue 1 lake, croscarmellose sodium, dicalcium phosphate, hydroxypropylcellulose, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, pregelatinized corn starch, PVP, silica, sodium carboxymethyl starch, stearic acid (283-056)


  • PRINCIPAL DISPLAY PANEL

    Unisom®
    PM PAIN
    SLEEPCAPS
    TM 
    30 Caplets

    Unisom®
PM PAIN
SLEEPCAPSTM 
30 Caplets


  • INGREDIENTS AND APPEARANCE
    UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER 
    acetaminophen and diphenhydramine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0040
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color WHITE (White and blue) Score 2 pieces
    Shape OVAL Size 20mm
    Flavor Imprint Code UNISOM;PM;PAIN
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0040-2 1 in 1 CARTON 12/01/2009
    1 15 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:41167-0040-3 1 in 1 CARTON 12/01/2009 04/10/2018
    2 20 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:41167-0040-4 1 in 1 CARTON 12/01/2009
    3 30 in 1 BOTTLE; 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 12/01/2009
    Labeler - Chattem, Inc. (003336013)