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Pain Relief PM Nightime Sleep Aid (Select Corporation)

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TABLET, COATED 2 TABLET, COATED in 1 PACKET (52904-445-02) Label Information

Complete Pain Relief PM Nightime Sleep Aid Information

  • ACTIVE INGREDIENT

    Active Ingredients

    Acetaminophen 500 mg.......................Pain Reliever/Fever Reducer
    Diphenhydramine HCl 25 mg..............................Nighttime Sleep Aid




  • PURPOSE

    Pain Reliever, Nightime Sleep Aid


  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 years of age and older:
    Take 2 tablets at bedtime, do not exceed 2 tablets (50 mg) in 24
    hours, or as directed by a doctor. Children under 12 years:
    Consult a doctor


  • INDICATIONS & USAGE

    Uses: Temporarily relieves: occasional headaches with minor
    aches and pains for relief of occasional sleeplessness Temporarily
    relieves itchy eyes and runny nose associated with: common
    allergies hay fever Warnings:


  • WARNINGS

    hildren under 12 years of age:
    Do not give to children under 12 years of age. Liver Warning: This
    product contains acetaminophen. Severe liver damage may occur if
    you take: more than 2 tablets in 24 hours with other drugs
    containing acetaminophen (prescription or nonprescription). Ask a
    doctor or pharmacist before using with other drugs if you are not
    sure. 3 or more alcoholic drinks every day while using this product
    Caution: This product will cause drowsiness. do not drive a motor
    vehicle or operate machinery after use. avoid alchoholic
    beverages while taking this product do not take this product if you
    are taking sedatives or tranquilizers, without first consulting your
    doctor if sleeplessness persists continuously for more than 2
    weeks, consult your doctor. Insomnia may be a symptom of serious
    underlying medical illness. Do not use: more than the
    recommended dose do not take this product unless directed by a
    doctor, if you have a breathing problem such as emphysema or
    chronic bronchitis, or if you have glaucoma or difficulty in urination
    due to enlargement of the prostate glandwith any other product containing
    acetaminophen this will provide more than the
    recommended dose (overdose) of acetaminophen
    and could cause serious health concerns. with any
    other product containing diphenhydramine, even one
    used on the skin for more than 10 days for pain unless
    directed by a doctor for more than 3 days for fever unless
    directed by a doctor. when using this product do not exceed
    recommended dose. Stop use and ask a doctor if:
    symptoms do not improve within 7 days or are accompanied by
    a fever pain or fever persists or gets worse new symptoms
    occur redness or swelling is present nervousness, dizziness or
    sleeplessness occur Ask a doctor before use if you have:
    heart disease high blood pressure thyroid disease diabetes
    difficulty in urination due to enlargement of the prostate gland

    In case of
    overdose, get medical help or contact a Poison Control Center
    right away. Prompt medical attention is critical for adults as well as
    for children even if you do not notice any signs or symptoms
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby, ask a health professional
    before use.


  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.


  • INACTIVE INGREDIENT

    Inactive Ingredients: corn starch, FDC Blue 1, maltodextrin,
    microcrystalline cellulose, polyethylene glycol, povidone, sodium
    starch glycolate, and stearic acid


  • PRINCIPAL DISPLAY PANEL

    MM1

    Pain PM Packet


  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PM NIGHTIME SLEEP AID  
    acetaminophen,diphenhydramine hcl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-445
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color blue (sky blue) Score no score
    Shape ROUND (S) Size 12mm
    Flavor Imprint Code S
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52904-445-02 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 10/15/2012
    Labeler - Select Corporation (053805599)