Label: UNISOM PM PAIN NIGHTTIME SLEEP AID AND PAIN RELIEVER- acetaminophen and diphenhydramine hydrochloride tablet

  • NDC Code(s): 41167-0040-2, 41167-0040-3, 41167-0040-4
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 5, 2010

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredients

    (in each caplet)

    Acetaminophen 325 mg

    Close
  • Purposes

    Pain reliever

    Close
  • Active ingredients

    (in each caplet)

    Diphenhydramine HCl 50 mg

    Close
  • Purposes

    Nighttime sleep-aid

    Close
  • Uses

    • for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
    Close
  • 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.

    Close
  • 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

    Close
  • 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)

    Close
  • PRINCIPAL DISPLAY PANEL

    Unisom®
    PM PAIN
    SLEEPCAPSTM 
    30 Caplets

    PRINCIPAL DISPLAY PANEL
Unisom PM Pain Nighttime Sleep-Aid and Pain Reliever

    Close
  • 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)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STARCH, PREGELATINIZED 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
    1 15 in 1 BOTTLE
    2 NDC:41167-0040-3 1 in 1 CARTON
    2 20 in 1 BOTTLE
    3 NDC:41167-0040-4 1 in 1 CARTON
    3 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part338 12/01/2009
    Labeler - Chattem, Inc. (003336013)
    Establishment
    Name Address ID/FEI Business Operations
    Chattem Plant 1 003336013 PACK
    Establishment
    Name Address ID/FEI Business Operations
    Contract Pharmacal Corp 057795122 MANUFACTURE
    Close