Label: PAIN AID ESF - acetaminophen, aspirin and caffeine tablet 

  • NDC Code(s): 35418-560-02, 35418-560-67, 35418-560-68, 35418-560-70
  • Packager: Zee Medical Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • ACTIVE INGREDIENT

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

    Close
  • PURPOSE

    Purpose-Pain reliever, Fever Reducer

    Close
  • INDICATIONS & USAGE

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

    Close
  • 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 Close
  • 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

    Close
  • PREGNANCY OR BREAST FEEDING

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

    Close
  • 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.

    Close
  • 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

    Close
  • PRINCIPAL DISPLAY PANEL

    MM1ESF 250 Box 1

    Close
  • INGREDIENTS AND APPEARANCE
    PAIN AID ESF 
    acetaminophen, aspirin, caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:35418-560
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 250 mg
    ASPIRIN (ASPIRIN) ASPIRIN 250 mg
    CAFFEINE (CAFFEINE) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE  
    STARCH, CORN  
    MALTODEXTRIN  
    POLYETHYLENE GLYCOL 300  
    POVIDONE K29/32  
    SODIUM LAURYL SULFATE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color white (snow white) Score no score
    Shape ROUND (ZEE;ESF) Size 12mm
    Flavor Imprint Code ZEE;ESF
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:35418-560-68 50 in 1 CARTON
    1 NDC:35418-560-67 125 in 1 CARTON
    1 NDC:35418-560-70 12 in 1 CARTON
    1 NDC:35418-560-02 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 06/12/2012
    Labeler - Zee Medical Inc (009645623)
    Registrant - Ultra Seal Corporation (085752004)
    Establishment
    Name Address ID/FEI Business Operations
    Ultratab Laboratories, Inc. 151051757 manufacture(35418-560)
    Establishment
    Name Address ID/FEI Business Operations
    Ultra Seal Corporation 085752004 repack(35418-560)
    Close