Label: MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH- acetaminophen tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated February 5, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    For the temporary relief of minor aches and pains associated with

    •
    headache
    •
    toothache
    •
    minor arthritis pain
    •
    muscular aches
    •
    common cold
    •
    menstrual cramps

    For the reduction of fever.

  • Warnings

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

    •
    more than 8 tablets 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.
    •
    for more than 10 days for pain unless directed by a doctor
    •
    for more than 3 days for fever unless directed by a doctor

    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 using and ask a doctor if

    •
    symptoms do not improve
    •
    pain or fever persists or gets worse
    •
    new symptoms occur
    •
    redness or swelling is present

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    •
    do not use more than directed

    Adults and children: (12 years and older)

    Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

    Children under 12 years:

    Do not give this adult strength product to children under 12 years of age;

    this will provide more than the recommended dose (overdose) and may cause liver damage.

  • Other information

    •
    store at room temperature 59º-86ºF (15º-30ºC)
    •
    tamper-evident sealed packets
    •
    do not use any opened or torn packets
  • Inactive ingredients

    corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized corn starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

    * May contain

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • Medi-First Plus XS Non-Aspirin Label

    8 Tablets

    Extra Strength

    Non-Aspirin

    Acetaminophen/Acetaminofeno 500mg

    Pull To Open

    Tire Para Abrir

    Pain Reliever/Fever Reducer

    Alivia el Dolar/Reduce La Fiebre

    Compare Active ingredient to:

    Extra Strength Tylenol®

    Registered Trademark of McNeil Consumer

    Tamper Evident Unit Dose Packets

    Empaquetado con sellado

    Evidente en dosis unitarias

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    71205-314-08
  • INGREDIENTS AND APPEARANCE
    MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH 
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-314(NDC:47682-804)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code AZ;235
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-314-044 in 1 PACKET; Type 0: Not a Combination Product09/01/2019
    2NDC:71205-314-088 in 1 PACKET; Type 0: Not a Combination Product02/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/30/2008
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-314) , RELABEL(71205-314)
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