EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMACEUTICALS]

EXTRA STRENGTH ACETAMINOHPEN ADULT RAPID BURST CHERRY (ACETAMINOPHEN) LIQUID [MAJOR PHARMACEUTICALS]
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NDC 0904-5847-09
Set ID 9e7543d9-6249-45b5-b67d-c1b439423b9c
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART341
  • Active Ingredients (in each 15 mL)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/Fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to
      • the common cold
      • headache
      • backache
      • minor pain of arthritis
      • toothache
      • muscular aches
      • premenstrual and menstrual cramps
    • temporarily reduces fever 
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4000 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
  • 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 for more than 10 days
    • fever gets worse or lasts for 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: Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) 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)
    • do not take more than 4 doses in any 24 hour period
    • measure only with dosing cup provided. Do not use any other dosing device
    • mL=milliliter
    • keep dosing cup with product
    • adults and children 12 years and over
      • 30 mL every 6 hours while symptoms last
      • do not take more than 10 days unless directed by a doctor
    • children under 12 years: do not use 
  • Other Information

    • each 15 mL contains: sodium 6 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate
    • protect from light
  • Inactive Ingredients

    citric acid, D&C red #33, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

  • Principal Display Panel

    Major Mapap

    ADULT

    For ages 12 years and over

    Extra Strength Actetaminophen 500 mg

    Rapid Burst Cherry

    Pain reliever

    fever reducer

    *COmpare to Extra strength Tylenol® active ingredient

    Alcohol free

    FL OZ (mL)

    Questions or comments?
    Call 1-877-753-3935

    Monday-Fridat 9AM-5PM EST

    Distributed by: MAjor Pharmaceuticals

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152 USA

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSSING.

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®

  • Package label

    acetominophen 500 mg

    Major MAPAP

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH ACETAMINOHPEN  ADULT RAPID BURST CHERRY
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5847
    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)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Tylenol Type Cherry Rapid Blast Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5847-09237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/02/200904/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/02/200904/26/2024
    Labeler - Major Pharmaceuticals (191427277)