PAIN AID ESF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [ZEE MEDICAL INC]

PAIN AID ESF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [ZEE MEDICAL INC]
PDF | XML

NDC 35418-560-02, 35418-560-67, 35418-560-68, 35418-560-70
Set ID d2d2c37e-5550-4dfc-9551-45164c06b92d
Category HUMAN OTC DRUG LABEL
Packager Zee Medical Inc
Generic Name
Product Class
Product Number
Application Number PART343
  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)  Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg

  • PURPOSE

    Purpose-Pain reliever, Fever Reducer

  • INDICATIONS & USAGE

    Uses
    ■ temporarily relieves pain due to:
    ■ headache ■ muscular aches ■ colds ■ flu
    ■ temporarily reduces fever

  • DOSAGE & ADMINISTRATION

    Directions

    • adults: take 2 tablets every 6 hours, not more than 8 tablets in

    24 hours

    • children under 12 years: ask a doctor
  • WARNINGS


    Warnings
    Reye's syndrome: Children and teenagers who have or are
    recovering from chicken pox or flu-like symptoms should not use
    this product. When using this product, if changes in behavior with
    nausea and vomiting occur, consult a doctor because these
    symptoms could be an early sign of Reye's syndrome, a rare but
    serious illness.
    Allergy alert: Aspirin may cause a severe allergic reaction which
    may include:
    ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock
    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
    Stomach bleeding warning: This product contains a
    nonsteroidal anti-inflammatory drug (NSAID), which may cause
    severe stomach bleeding. The chance is higher if you
    ■ are age 60 or older
    ■ have had stomach ulcers or bleeding problems
    ■ take a blood thinning (anticoagulant) or steroid drug
    ■ take other drugs containing prescription or nonprescription
    NSAIDs (aspirin, ibuprofen, naproxen, or others)
    ■ have 3 or more alcoholic drinks every day while using this product
    ■ take more or for a longer time than directed
    Caffeine warning: The recommended dose of this product
    contains about as much caffeine as a cup of coffee. Limit the use of
    caffeine-containing medications, foods, or beverages while taking
    this product because too much caffeine may cause nervousness,
    irritability, sleeplessness, and, occasionally, rapid heart beat.
    Do not use
    ■ if you have ever had an allergic reaction to any other pain
    reliever/fever reducer
    ■ with any other drug containing acetaminophen (prescription
    or nonprescription). If you are not sure whether a drug
    contains acetaminophen, ask a doctor or pharmacist.
    Stop use and ask a doctor if
    ■ an allergic reaction occurs. Seek medical help right away.
    ■ you experience any of the following signs of stomach bleeding:
    ■ feel faint ■ vomit blood ■ have bloody or black stools
    ■ have stomach pain that does not get better
    ■ ringing in the ears or loss of hearing occurs
    ■ pain gets worse or lasts more than 10 days
    ■ fever gets worse or lasts more than 3 days
    ■ redness or swelling is present in the painful area
    ■ any new symptoms appearAsk a doctor before use if you are taking a prescription drug for diabetes, gout, or arthritis■ stomach bleeding warning applies to you■ you have a history of stomach problems, such as heartburn you have asthma, high blood pressure, heart disease, live rdisease, or kidney disease■ you are taking a diuretic

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. In case of 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.

  • INACTIVE INGREDIENT

    Inactive ingredients cellulose*, hydroxypropyl
    methylcellulose, maltodextrin*, polyethylene glycol, povidone,
    propylene glycol*, sodium lauryl sulfate*, sodium starch
    glycolate, starch, stearic acid, titanium dioxide
    *contains one or more of these ingredients

  • PRINCIPAL DISPLAY PANEL

    MM1ESF 250 Box 1

  • INGREDIENTS AND APPEARANCE
    PAIN AID ESF 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35418-560
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POVIDONE K29/32 (UNII: 390RMW2PEQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (snow white) Scoreno score
    ShapeROUND (ZEE;ESF) Size12mm
    FlavorImprint Code ZEE;ESF
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35418-560-6850 in 1 CARTON06/12/2012
    1NDC:35418-560-67125 in 1 CARTON
    1NDC:35418-560-7012 in 1 CARTON
    1NDC:35418-560-022 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/12/2012
    Labeler - Zee Medical Inc (009645623)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultratab Laboratories, Inc.151051757manufacture(35418-560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004repack(35418-560)

Related Drugs