EXTRA STRENGTH PAIN RELIEVER TABLET [REDICARE LLC]

EXTRA STRENGTH PAIN RELIEVER TABLET [REDICARE LLC]
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NDC 71105-242-68
Set ID 47df5786-b918-3a3e-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Redicare LLC
Generic Name
Product Class
Product Number
Application Number PART343
  • Active Ingredient

    Acetaminophen 110 mg .....................................................................................pain reliever/fever reducer

    Aspirin 162 mg .....................................................................................................pain reliever/fever reducer

    Caffeine 32.4 mg...............................................................................................................................adjuvant

    Salicylamide 152 mg............................................................................................pain reliever/fever reducer

  • Uses:

    temporarily relieves minor aches and pains associated with ■ headaches ■ colds ■ a toothache ■ minor arthritis pain ■ muscular aches ■ menstrual cramps ■ a backache

  • Warnings: Reye’s syndrome:

    Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s syndrome, a rare but serious illness reported to be associated with aspirin.

  • Liver Warning:

    This product contains Acetaminophen. Severe liver damage may occur if: ■ you take more than 8 tablets in 24 hours ■ you take with other drugs containing acetaminophen (prescription or non-prescription) ■ you have 3 or more alcoholic drinks every day while using this product.

  • Stomach Bleeding Warning:

    This product contains a non-steroidal anti-inflammatory drug (NSAIDs), which may cause stomach bleeding. The chance is higher if you ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ are age 60 or older ■ have 3 or more alcoholic drinks every day while using this product ■ take with other drugs containing a NSAID ■ you take more or for a longer time than directed.

  • Do not use:

    ■ if you are allergic to aspirin ■ with any other pain reliever/fever reducer ■ 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 ■ with any other product containing acetaminophen

  • Ask doctor before using if you have:

    ■ asthma ■ stomach problems (such as heartburn, upset stomach or stomach pain) ■ gastric ulcers ■ bleeding problems

  • Ask a doctor or pharmacist before use if

    you are taking a prescription drug for ■ anticoagulation (thinning of blood) ■ diabetes ■ gout ■ arthritis

  • 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

  • If pregnant or breast-feeding a 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 a 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.

  • Directions:

    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 6 tablets in any 24 hour period
    Children under 12 years: Ask a doctor

  • Other Information:

    ■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity

  • Inactive Ingredients:

    FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch and stearic acid

  • PRINCIPAL DISPLAY PANEL

    Box

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEVER 
    extra strength pain reliever tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-242
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN162 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN110 mg
    SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE152 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.4 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    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:71105-242-68100 in 1 CARTON; Type 0: Not a Combination Product10/01/2017
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/01/2017
    Labeler - Redicare LLC (800149346)

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