Label: ACETAMINOPHEN tablet, film coated, extended release

  • NDC Code(s): 0363-0336-01, 0363-0336-02, 0363-0336-24
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 4, 2019

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

View All Sections
  • ACTIVE INGREDIENT (IN EACH CAPLET)

    Acetaminophen USP, 650 mg

  • PURPOSE

    Pain reliever/fever reducer

  • USES

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

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

    •
    more than 6 caplets in 24 hours, which is the maximum daily amount
    •
    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

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

    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.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is 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 (see overdose warning)

    adults and children 12 years and over

    ▪ take 2 caplets every 8 hours with water
    ▪ swallow whole; do not crush, chew, split or dissolve
    ▪ do not take more than 6 caplets in 24 hours
    ▪ do not use for more than 10 days unless directed by a doctor

    children under 12 years

    ▪ do not use
  • OTHER INFORMATION

    •
    store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
    •
    see end panel for batch number and expiration date
    •
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • INACTIVE INGREDIENTS

    Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

  • QUESTIONS?

    Call 1-800-406-7984

  • PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

    Walgreens

    Compare to Tylenol® 8 HR Muscle
    Aches & Pain active ingredient††

    NDC 0363-0336-24

    8-Hour
    Pain Reliever

    ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP,
    650 mg / PAIN RELIEVER / FEVER REDUCER

    MUSCLE PAIN
    8 HOUR
    CAPLETS

    •
    Relieves minor muscle pain for up to 8 hours

    100
    CAPLETS*
    (*CAPSULE-SHAPED TABLETS)

    ACTUAL SIZE

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    spl-apap-walgreens-100-caplet-bottle-carton
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0336
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (Capsule Shaped) Size19mm
    FlavorImprint Code cor116
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0336-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2002
    2NDC:0363-0336-2424 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2002
    3NDC:0363-0336-02200 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07620004/30/2002
    Labeler - Walgreen Company (008965063)
    Registrant - Sun Pharmaceutical Industries Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029MANUFACTURE(0363-0336)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!