Label: MOORE MEDICAL EXTRA STRENGTH NON ASPIRIN- acetaminophen tablet, film coated

  • NDC Code(s): 55670-468-13, 55670-468-99
  • Packager: Moore Medical LLC
  • 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 March 13, 2017

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Acetaminophen 500mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    For the temporary relief of minor aches and pains associated with

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

    For the reduction of fever.

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  • 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
    • new symptoms occur
    • pain or fever persists or gets worse
    • redness or swelling is present

    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.

    If pregnant or breast-feeding, ask a health professional before use.

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  • 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 to children under 12 years of age.

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  • Other information

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

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

    * may contain

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  • Questions or comments? 1-800-234-1464
  • Moore Medical XS Non Aspirin Label

    moore medical

    Supporting Health & Care

    Reorder No. 82468

    UPN# 0-0607415-82468-1

    Moore Brand®

    Extra Strength

    Non-Aspirin

    Pain Reliever

    250 Packets/2 Tablets

    Each Packet Net Wt. 1000 mg

    Acetaminophen 500 mg

    Reorder No.: 82468

    To Reorder:

    Call: 1.800.234.1464

    Fax: 1.800.944.6667

    Online: www.mooremedical.com

    175R  MM XS Non Aspirin

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  • INGREDIENTS AND APPEARANCE
    MOORE MEDICAL EXTRA STRENGTH NON ASPIRIN 
    acetaminophen tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55670-468
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (ROUND) Size 12mm
    Flavor Imprint Code AZ;235
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55670-468-13 250 in 1 BOX 12/30/2008
    1 NDC:55670-468-99 2 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 12/30/2008
    Labeler - Moore Medical LLC (051420107)
    Establishment
    Name Address ID/FEI Business Operations
    Prestige Packaging 170837962 relabel(55670-468) , repack(55670-468)
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