Label: ACETAMINOPHEN CAPLETS- acetaminophen tablet

  • NDC Code(s): 70729-001-24, 70729-001-50, 70729-175-12
  • Packager: Breeden Brothers, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 15, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • 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

    Drug Facts (continued)

  • 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

    Allergy alert: Acetaminophen may cause severe skin reactions.

    Symptoms may include: _ rash _ blisters

    _ skin reddening 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

    Drug Facts (continued)

    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

    Drug Facts (continued)

    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

    _ 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

  • Other information

    _ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

    _ use by expiration date on package

    Drug Facts (continued)

  • Inactive ingredients

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

  • Questions or comments?

    1-800-901-2420

    Dist. by Breeden Brothers, LLC
    Nashville, TN 37219

  • PRINCIPAL DISPLAY PANEL

    b+b
    better by giving
    EXTRA STRENGTH
    PAIN RELIEVER
    acetaminophen
    Pain Reliever/Fever Reducer
    50 Caplets
    (500 mg each)

    PRINCIPAL DISPLAY PANEL b+b better by giving EXTRA STRENGTH PAIN RELIEVER acetaminophen Pain Reliever/Fever Reducer 50 Caplets (500 mg each)

  • PRINCIPAL DISPLAY PANEL

    b+b
    NDC 70729-175-12
    EXTRA STRENGTH
    PAIN RELIEVER
    acetaminophen 500 mg
    Pain Reliever/Fever Reducer
    100 Caplets

    b+b NDC 70729-175-12 EXTRA STRENGTH PAIN RELIEVER acetaminophen 500 mg Pain Reliever/Fever Reducer 100 Caplets

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN CAPLETS 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70729-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;175
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70729-001-2424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2017
    2NDC:70729-001-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34305/01/2017
    ACETAMINOPHEN CAPLETS 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70729-175
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;175
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70729-175-12100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34305/01/2017
    Labeler - Breeden Brothers, LLC (080131046)
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