UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]

UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHATTEM, INC.]
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NDC 41167-0040-2, 41167-0040-3, 41167-0040-4
Set ID 451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb
Category HUMAN OTC DRUG LABEL
Packager Chattem, Inc.
Generic Name
Product Class
Product Number
Application Number PART338
  • 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, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0040
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITE (White and blue) Score2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code UNISOM;PM;PAIN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0040-21 in 1 CARTON12/01/2009
    115 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41167-0040-31 in 1 CARTON12/01/200904/10/2018
    220 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:41167-0040-41 in 1 CARTON12/01/2009
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/01/2009
    Labeler - Chattem, Inc. (003336013)

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