Label: MEDI-FIRST NON-ASPIRIN- acetaminophen tablet, 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 October 1, 2019

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  • Drug Facts

  • Active ingredient (in each tablet)

    Acetaminophen 325 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    For the temporary relief of minor aches and pains associated with

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

    For the reduction of fever.

  • Warnings

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

    •
    more than 12 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
    •
    new symptoms occur
    •
    pain or fever persists or gets worse
    •
    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 12 tablets in 24 hours.

    Children under 12 years:

    Do not give to children under 12 years of age.

    Other information

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

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

    * may contain

  • Questions or comments?

    1-800-634-7680

  • Medi-First Non-Aspirin 325 mg Label

    4 Tablets

    71205-306-04

    Medi-First ®

    Non-Aspirin

    Aches, Fever ● Acetaminophen 500mg

    Dolores, Fiebre ● Acetaminofeno 500mg

    Aspirin-Free Pain Relief

    Pull to Open

    Tire Para Abrir

    Compare active ingredients to:

    Compare el ingrediente activo con:

    Extra Strength Tylenol®

    Registered Trademark of McNeil Consumer Products

    Marca Registrada de McNeil Consumer Products

    Tamper Evident Unit Dose Packets

    Empaquetado con Sellado

    Evidente en Dosis Unitarias

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    71205-306-04
  • INGREDIENTS AND APPEARANCE
    MEDI-FIRST NON-ASPIRIN 
    acetaminophen tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-306(NDC:47682-803)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 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) Size10mm
    FlavorImprint Code AZ;234
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-306-044 in 1 PACKET; Type 0: Not a Combination Product08/01/2019
    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 LP079196022RELABEL(71205-306)
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