Label: PAIN RELIEVER- acetaminophen tablet

  • NDC Code(s): 15127-735-05, 15127-735-08, 15127-735-09, 15127-735-16, view more
    15127-735-19
  • Packager: L&R Distributors, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/15

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

  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • the common cold
      • backache
      • minor pain of arthritis
      • toothache
      • muscular aches
      • premenstrual and menstrual cramps
    • temporarily reduces fever
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  • Warnings

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. 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

    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

    • if you are allergic to acetaminophen or any of the inactive ingredients in this product 
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if you have

    liver disease.

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    • pain gets worse or lasts 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.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    • do not take more than directed
    • adults and children 12 years and over
      • take 2 caplets every 6 hours while symptoms last
      • do not take more than 6 caplets in 24 hours, unless directed by a doctor
      • do not take for more than 10 days unless directed by a doctor
    • children under 12 years: ask a doctor
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
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  • Inactive Ingredients

    caster oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    select brand®
    the lower price name brand

    TAMPER EVIDENT: Use Only If This Blister is Intact 

    NDC 15127-735-19

    EXTRA STRENGTH/NON-ASPRIN

    PAIN RELIEVER

    ACETAMINOPHEN 500 mg 
    PAIN RELIEVER/FEVER REDUCER

    *Compare to the Active Ingredient of Extra Strength Tylenol® Caplets

    500 mg EACH

    8 CAPLETS

    This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Caplets.
    50844         ORG071517519

    SATISFACTION
    GUARANTEED
    select
    brand®

    Distributed by:
    SELECT BRAND® DISTRIBUTORS
    Pine Bluff, AR 71603   USA
    AC (870) 535-3635

    Select Brand 44-175

    Select Brand 44-175

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  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-735
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POVIDONES (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL (Tablet) Size 18mm
    Flavor Imprint Code 44;175
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:15127-735-19 2 in 1 CARTON
    1 4 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:15127-735-09 1 in 1 CARTON
    2 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3 NDC:15127-735-16 1 in 1 CARTON
    3 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4 NDC:15127-735-08 1 in 1 CARTON
    4 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5 NDC:15127-735-05 500 in 1 BOTTLE, PLASTIC; 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 04/02/1993
    Labeler - L&R Distributors, Inc. (012578514)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(15127-735)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(15127-735)
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