Regular Strength Aspirin EC description, usages, side effects, indications, overdosage, supplying and lots more!

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Regular Strength Aspirin EC

Aidarex Pharmaceuticals LLC

DRUG FACTS




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredient (in each tablet)                  Purpose

Aspirin 325 mg (NSAID*).............................Pain reliever

*nonsteroidal anti-inflammatory drug

Purpose

Purpose
Pain reliever

Uses

Uses 

  • for the temporary relief of minor aches and pains due to
    • headache
    • colds
    • muscle pain
    • menstrual pain
    • toothache
    • minor pain of arthritis
  • or as directed by your doctor

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 or 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 inclue:

  • hives
  • facial swelling
  • shock
  • asthma (wheezing)

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 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 are allergic to aspirin or 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
  • you have not been drinking fluids

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout, or arthritis
  • taking any other drugs
  • under a doctor's care for any serious condition

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • 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 appear
  • ringing in the ears or a loss of hearing occurs

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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: consult a doctor

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive ingredients corn starch, croscarmellose sodium, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions? To Report Adverse Drug Event Call: (800) 616-2471

Regular Strength Aspirin EC

Regular Strength Aspirin EC

Aspirin TABLET, DELAYED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33261-153(NDC:0904-2013)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 325 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
cellulose, microcrystalline
Mineral Oil
polysorbate 80
SILICON DIOXIDE
DIMETHICONE
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
talc
titanium dioxide
TRIETHYL CITRATE

Product Characteristics

Color Size Imprint Code Shape
ORANGE 11 mm T ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33261-153-02 120 in 1 BOTTLE, PLASTIC
2 NDC:33261-153-14 14 in 1 BOTTLE, PLASTIC
3 NDC:33261-153-30 30 in 1 BOTTLE, PLASTIC
4 NDC:33261-153-60 60 in 1 BOTTLE, PLASTIC
5 NDC:33261-153-90 90 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2011-09-09


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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