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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 5, 2020

If you are a consumer or patient please visit this version.

  • 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)