Label: ANACIN- asprin and caffeine tablet

  • NDC Code(s): 63736-200-04, 63736-200-30, 63736-200-50, 63736-200-90, view more
    63736-200-91, 63736-200-92, 63736-200-93, 63736-200-95
  • Packager: Insight Pharmaceuticals 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 July 2, 2020

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  • SPL UNCLASSIFIED SECTION

    ANACIN- asprin and caffeine tablet Insight Pharmaceuticals

    ANACIN®

    Drug Facts

  • Active ingredients (per tablet)

    Aspirin (NSAID)* 400 mg
    Caffeine 32 mg

    * nonsteroidal anti- inflammatory drug

  • Purposes

    Pain reliever
    Pain reliever aid

  • Uses

    temporarily relieves minor aches and pains due to

    • Headache
    • toothache
    • muscular aches
    • a cold
    • backache
    • arthritis
    • menstrual cramps
  • 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

    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 thinner (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

    Do not use 

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

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic
    • you have asthma

    Ask a doctor or pharmacist before use if

    you are taking a prescription drug for diabetes, gout, or arthritis

    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
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs
    • redness or swelling is present
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days

    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.

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely 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.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • do not use more than directed (see overdose warning)
    • drink a full glass of water with each dose
    • adults and children 12 years of age and older: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor
    • children under 12 years of age: do not use

    Other information

    Keep carton for full drug facts and warnings.

    Store at 15 – 25°C (59– 77°F). Protect from moisture.

  • Inactive ingredients

    corn starch, hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

  • Questions?

    1-800-344-7239 anacin.com

  • PRINCIPAL DISPLAY PANEL

    ANACIN®

    Aspirin (NSAID) Pain Reliever / Caffeine Pain Reliever Aid

    100 COATED TABLETS

    ANACIN® Aspirin (NSAID) Pain Reliever / Caffeine Pain Reliever Aid 100 COATED TABLETS

  • INGREDIENTS AND APPEARANCE
    ANACIN 
    asprin and caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN400 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-200-041 in 1 BOX06/25/200906/30/2023
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63736-200-931 in 1 BOX06/25/2009
    2300 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:63736-200-301 in 1 BOX06/25/200906/30/2023
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:63736-200-501 in 1 BOX06/25/2009
    450 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:63736-200-901 in 1 BOX06/25/2009
    5100 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:63736-200-911 in 1 BOX06/25/200906/30/2023
    6130 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:63736-200-92125 in 1 BOX06/25/2009
    71 in 1 POUCH; Type 0: Not a Combination Product
    8NDC:63736-200-95750 in 1 BOX06/25/200906/30/2023
    81 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34306/25/2009
    Labeler - Insight Pharmaceuticals LLC (055665422)
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