Label: ACETAMINOPHEN 325 MG- acetaminophen tablet

  • NDC Code(s): 69618-010-01, 69618-010-10
  • Packager: Reliable 1 Laboratories 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 October 1, 2015

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Acetaminophen USP, 325 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

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

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  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if

    • adult takes more than 4,000 mg in 24 hours, which is the maximum daily amount
    • child takes more than 5 tablets in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks while using this product
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  • OTHER SAFETY INFORMATION

    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.

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  • DO NOT USE

    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.

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  • ASK DOCTOR

    Ask a doctor before use if the user has liver disease

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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

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  • STOP USE

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days in adults
    • pain gets worse or lasts more than 5 days in children
    • 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.

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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    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.

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  • Directions

    • do not take more than directed (see overdose warning)
    adults and children 12 years and over take 2 tablets every 4-6 hours while symptoms last, not more than 12 tablets in 24 hours
    children 6 to 11 years take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours
    children under 6 years do not use

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  • Other information

    • store at 15° to 30°C (59° to 86°F)
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  • Inactive ingredients

    povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

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  • Questions or comments?

    call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

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  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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  • SPL UNCLASSIFIED SECTION

    *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.

    Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

    www.reliable1labs.com

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  • PRINCIPAL DISPLAY PANEL

    NDC 69618-010-01

    Regular Strength

    Acetaminophen USP 325 mg

    PAIN RELIEVER

    FEVER REDUCER

    100 TABLETS

    *Compare to Active Ingredient in Regular Strength TYLENOL®

    6961801001

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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 325 MG 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69618-010
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Color white Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code AP;012
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69618-010-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2015
    2 NDC:69618-010-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2015
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 11/01/2015
    Labeler - Reliable 1 Laboratories LLC (079718111)
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