Label: PAIN RELIEVER- acetaminophen, aspirin, caffeine, salicylamide tablet

  • NDC Code(s): 67060-113-67
  • Packager: ADVANCED FIRST AID, INC.
  • Category: HUMAN OTC DRUG LABEL

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 May 31, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT IN EACH TABLET- ACETAMINOPHEN 110 MG, ASPIRIN 162 MG, CAFFEINE 32.4 MG, SALICYLAMIDE 152 MG

  • PURPOSE

    PAIN RELIEVER/FEVER REDUCER 

  • INDICATIONS & USAGE

    Uses:

    temporarily relieves minor aches and pains associated with:

    • headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache

  • 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 behaviour 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.

    Alergy 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.

    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 an 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 with 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:

    • with any other product containing acetaminophen (prescription or nonprescription). This will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.

    • with any other pain reliever/fever reducer

    • if you are allergic to aspirin

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer

    • for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor

    Ask doctor before using if you have:

    • stomach problems (such as heartburn, upset stomach or stomach pain)

    • stomach bleeding warning applies to you

    • gastric ulcers • bleeding problems

    • you have asthma, high blood pressure, heart disease, liver disease, or kidney disease

    • you are taking a diuretic

    Ask a doctor or pharmacist before use if you are taking a prescription drug for:

    •anticoagulation (thinning of blood) • diabetes • gout • arthritis

    • und a doctor's care for any serious condition

    • taking any other drug

    When using this product do not exceed recommended dose.

    Stop use and ask a doctor if:

    • ringing in the ears or loss of hearing occurs

    • pain or fever persists or gets worse

    • new symptoms occur

    • redness or swelling is present

    • you feel faint, vomit blood or have bloody or black stools, have stomach pain that does not get better. These are signs of stomach bleeding.

    • an allergic reaction occurs.

    Seek medical help right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby, ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN

    DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT

    MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.

  • 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.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older:Take 2 tablets every 4 hours as

     needed, with a full glass of water. Do not exceed 8 tablets in any 24 hour period.

    Children under 12 years: ask a doctor.

  • INACTIVE INGREDIENT

    FD&C yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch and stearic acid

  • PRINCIPAL DISPLAY PANEL

    Pain Reliever 250ct boxPain Reliever 250ct box

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER 
    acetaminophen, aspirin, caffeine, salicylamide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-113
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN110 
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN162 
    SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE152 
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.4 
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colororange (ROSE ORANGE) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code FR2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67060-113-67250 in 1 CARTON05/31/2019
    12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/07/2015
    Labeler - ADVANCED FIRST AID, INC. (114477180)
    Registrant - ADVANCED FIRST AID, INC. (114477180)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION085752004pack(67060-113)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA TAB LABORATORIES, INC.151051757manufacture(67060-113)