Label: ACETAMINOPHEN EXTENDED RELEASE- acetaminophen tablet

  • NDC Code(s): 11822-6304-1, 11822-6304-2, 11822-6304-3
  • Packager: Rite Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 3, 2022

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  • Active ingredient (in each caplet)

    Acetaminophen USP, 650 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • minor pain of arthritis
      • backache
      • muscular aches
      • 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 ever 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 a 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. 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
      • 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
    • under 18 years of age: ask a doctor
  • Other information

    • store between 20-25°C (68-77°F)
  • Inactive ingredients

    hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid


  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    Compare to the active ingredient of Tylenol® 8 HR Arthritis Pain

    SEE NEW WARNING

    8 HR ARTHRITIS PAIN RELIEF

    ACETAMINOPHEN

    EXTENDED-RELEASE TABLETS USP 650 mg

    PAIN RELIEVER/FEVER REDUCER

    For the temporary relief of minor arthritis pain

    Contain no aspirin

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

    CAPLETS

    *CAPSULE-SHAPED BI-LAYER TABLETS

    †This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® 8 HR Arthritis Pain.

    TAMPER EVIDENT: DO NOT USE IF FOIL INNER SEAL IS BROKEN OR MISSING.

    DISTRIBUTED BY:

    RITE AID, 30 HUNTER LANE,

    CAMP HILL, PA 17011

    www.riteaid.com

  • Product Label

    Acetaminophen USP, 650 mg

    RITE AID PHARMACY Acetaminophen Extended-Release Tablets

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  EXTENDED RELEASE
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6304
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code G650
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-6304-11 in 1 BOX05/29/202005/29/2025
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:11822-6304-3225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/29/202005/29/2025
    3NDC:11822-6304-21 in 1 BOX05/29/202005/29/2025
    3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21154405/29/202005/29/2025
    Labeler - Rite Aid Corporation (014578892)
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