Anacin Tablet
FDA Label NDC 63736-200

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Anacin (NDC 63736-200). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (per tablet), purposes, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.

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?

Call 1-800-344-7239 or visit our website at

www.anacin.com

Dist. by Insight Pharmaceuticals, LLC.
Tarrytown, NY 10591

Principal Display Panel- 100 Tablet

ANACIN ®

Aspirin (NSAID) Pain Reliever / Caffeine Pain Reliever Aid

100 COATED TABLETS

* Please review the disclaimer below.