Label: ACETAMINOPHEN 650MG- acetaminophen tablet

  • NDC Code(s): 81877-850-30
  • Packager: Forreal Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 24, 2026

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  • Active ingredient (in each caplet)

    Acetaminophen 650 mg

  • Purpose

    Pain reliever/fever reducer

  • 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

  • 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


    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 at 20-25°C (68-77°F)

           do not use if printed foil under cap is broken or missing

           meets the requirements of USP Dissolution Test 4

  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

  • Questions or comments?

    1-877-367-3250

  • Principal Display Panel

    NDC 81877-850-30

    Forreal Pharmaceuticals LLC
    YOUR SOLUTION TO BETTER HEALTHCARE.

    Arthritis Pain
    ACETAMINOPHEN
    Extended - Release Tablets
    Pain reliever/ Fever Reducer
    For the Temporary Relief of Minor Arthritis Pain

    650 mg

    Capsule-Shaped Tablets

    30 Caplets
    TAMPER EVIDENT: DO NOT
    USE IF SAFETY SEAL IS BROKEN
    OR MISSING FROM BOTTLE.

    Marketed By:
    Forreal Pharmaceuticals, LLC
    Royal Oak MI 48067
    Questions or inquiries call
    877-367-3250

    acetaminophen-650.jpg
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 650MG 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81877-850
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code L544
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81877-850-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/15/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07507706/15/2026
    Labeler - Forreal Pharmaceuticals, LLC (118029197)
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