Label: EXTRA STRENGTH PAIN RELIEF- acetaminophen suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 22, 2024

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  • Active ingredient (in each 15mL Tablespoonful)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/Fever reducer

  • Uses

    •
    temporarily relieves minor aches and pains
    •
    temporarily reduces fever
  • Warnings

    Liver Warning: This product contains acetaminophen. The maximum
    daily dose of this product is 6 tablespoonfuls in 24 hours.
    Severe liver damage may occur if you take
    • more than 8 tablespoonfuls (4,000 mg of acetaminophen) in 24
    hours • 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 non-prescription). 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

    When using this product: Do not exceed recommended dose.

    Stop use and ask a doctor if

    •
    new symptoms occur
    •
    redness or swelling is present
    •
    pain gets worse or lasts more than 10 days
    •
    fever gets worse or lasts more than 3 days

    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. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

  • Directions

    •
    do not take more than directed

    Adults and children 12 years of age and older

    Take 1-2 Tablespoons every 4 to 6 hours as needed; not more than 6 Tablespoons in 24 hours

    Children under 12 years

    Do not use
  • Other information

    •
    store at room temperature 15°- 30°C (59°-86°F)
    •
    protect from freezing
    •
    protect from light
    •
    TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken or missing.
  • Inactive ingredients

    artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

  • Questions or comments?

    1-800-540-3765

    Relabeled By: Preferred Pharmaceuticals Inc.

  • PRINCIPAL DISPLAY PANEL

    Extra Strength APAP Liquid 500mg per 15mL
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEF 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8375(NDC:57896-206)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8375-2237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug34302/24/2023
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8375)
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