Label: ACETAMINOPHEN- acetaminophen tablet, extended release

  • NDC Code(s): 0363-0340-01, 0363-0340-20, 0363-0340-80
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 04/15

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

  • ACTIVE INGREDIENT (IN EACH GELTAB)

    Acetaminophen USP, 650 mg

    Close
  • PURPOSE

    Pain reliever/fever reducer

    Close
  • USES

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

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

    more than 6 geltabs 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

    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 have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
    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
    the tablet got stuck in your throat

    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.

    Close
  • DIRECTIONS

    do not take more than directed (see overdose warning)

    adults

    take 2 geltabs every 8 hours. Swallow only one geltab at a time.
    take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).
    swallow whole - do not crush, chew, split or dissolve
    do not take more than 6 geltabs in 24 hours
    do not use for more than 10 days unless directed by a doctor

    under 18 years of age

    ask a doctor
    Close
  • OTHER INFORMATION

    store at 20 - 25° C (68 - 77° F). Avoid high humidity.
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
    Close
  • INACTIVE INGREDIENTS

    Croscarmellose sodium, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch, titanium dioxide

    Close
  • QUESTIONS?

    Call 1-800-406-7984

    Close
  • PRINCIPAL DISPLAY PANEL

    Well at Walgreens

    NDC 0363-0340-01

    Arthritis Pain Reliever

    Acetaminophen Extended-release Tablets USP, 650 mg

    Pain Reliever / Fever Reducer

    For the temporary relief of minor arthritis pain

    100 GELTABS*

    (80+20 FREE) (*Gelatin-Coated tablets)

    Compare to Tylenol®Arthritis Pain active ingredient‡‡

    DISTRIBUTED BY: WALGREEN CO.

    5117003/ORG0415-F

    This is the 100 count blister carton label for Walgreens Acetaminophen extended-release tablets, USP 650 mg (geltabs).
    Close
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, extended release
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0340
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color white (White to Yellow) Score no score
    Shape ROUND Size 13mm
    Flavor Imprint Code 350
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0340-20 20 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:0363-0340-80 80 in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:0363-0340-01 100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078569 12/21/2012
    Labeler - Walgreen Company (008965063)
    Registrant - Ranbaxy Pharmaceuticals Inc. (947890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 184769029 MANUFACTURE(0363-0340)
    Close