Label: PAIN RELIEF tablet, extended release

  • NDC Code(s): 69168-461-03, 69168-461-32
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 24, 2024

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  • Active ingredient(s)

    Acetaminophen USP,  650 mg

  • Purpose

    Pain reliever/fever reducer

  • Use(s)


    • 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

  • 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 everyday 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 drugs 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

    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 breastfeeding,

    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

    •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 20º-25ºC (68º-77ºF)
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

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

  • Questions/Comments

    Call 1-888-952-0050 Monday to Friday 9am-5pm EST

  • Principal Display Panel

    Pain Relief

    Pain Relief

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF 
    pain relief tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-461
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    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:69168-461-32100 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2024
    2NDC:69168-461-03250 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21154404/24/2024
    Labeler - Allegiant Health (079501930)
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