Label: ACETAMINOPHEN tablet

  • NDC Code(s): 0904-7314-27, 0904-7314-60
  • Packager: MAJOR PHARMACEUTICALS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 18, 2024

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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

    ■ muscular aches

    ■ backache

    ■ premenstrual and menstrual cramps

    ■ the common cold

    ■ headache

    ■ toothache

    ■ temporarily reduces fever

  • Liver 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

    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 20-25°C (68-77°F)
    ■ do not use if foil inner seal is broken or missing

  • Inactive ingredients

    hydroxy ethyl cellulose, hypromellose,magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

  • Questions or comments?

    contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

  • PDP

    APAP 650mg 400ctAPAP 650mg 100ct

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7314
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE K30 (UNII: U725QWY32X)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    Colorwhite (WHITE TO OFF WHITE COLORED) Scoreno score
    ShapeOVAL (CAPSULE SHAPED, BICONVEX INTACT FILM COATED TABLETS) Size19mm
    FlavorImprint Code G;650
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7314-27400 in 1 BOTTLE; Type 0: Not a Combination Product03/03/2023
    2NDC:0904-7314-60100 in 1 BOTTLE; Type 0: Not a Combination Product03/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21154403/03/2023
    Labeler - MAJOR PHARMACEUTICALS (191427277)
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