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aspirin

Cardinal Health


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient in Each tablet

Aspirin 81 mg (NSAID*) *Non-steroidal anti-inflammatory drug

Purpose

Purpose Pain Reliever

Uses- Temporarily relieves minor aches and pains- For other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.

Inactive ingredients: anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Storage: Store at 25C (77F) excursions permitted between 15-30C (59-86F) - use by expiration date on package

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

WARNING: This package is intended for institutional use only. 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

SKY

Mfg. By: Time-Cap Labs

7 Michael Ave.

Farmingdale, NY 11735

Dist. By: McKesson Packaging Services

a business unit of McKesson Corporation

7101 Weddington Rd. Concord, NC 28027

*This product is not maufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Bayer

Directions:  drink a full glass of water with each dose; adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor

Children under 12 years - consult a doctor


Allergy alert: Aspirin may cause a severe allergic reaction which may include: 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, hae had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or non prescription 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 you have - stomach bleeding waring 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- you have lost a lot of fluid due to vomiting or diarrhea

Uses

Ask a doctor or pharmacist before use if you are- taking a prescription drug for diabetes, gout, or arthritis- under a doctor's care for any serious condition- taking any other drug

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

Principal Display Panel

Aspirin Enteric Coated Tablets

81 mg

10 Tablets

aspirin

aspirin

aspirin TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-1493(NDC:63739-522)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 81 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS LACTOSE
carnauba wax
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
IRON
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
cellulose, microcrystalline
DIMETHICONE
polysorbate 80
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
talc
titanium dioxide
TRIETHYL CITRATE

Product Characteristics

Color Size Shape
YELLOW 7 mm ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:55154-1493-0 10 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-11-13


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Be sure to consult your doctor before taking any medication!
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