Aspir Low description, usages, side effects, indications, overdosage, supplying and lots more!

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Aspir Low

Unit Dose Services
Unit Dose Services

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Keep Out of Reach of Children

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

Aspir Low 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

Warnings

Children and teenagers who have or are recovering from chicken pox or flulike Reyeʼs syndrome:

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.

Aspirin may cause a severe allergic reaction, which may include: Allergy alert:

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

This product contains an NSAID, which may cause severe stomach Stomach bleeding warning:

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

■ if you are allergic to aspirin or any other pain reliever/fever reducer Do not use

■ stomach bleeding warning applies to you Ask a doctor before use if

■ 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

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

■ you experience any of the following signs of stomach bleeding: Stop use and ask a doctor if

■ 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

, ask a health professional before use. It is especially important not If pregnant or breast-feeding

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.

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

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

Questions?

Adverse Drug Event Call: (800) 616-2471

Other Information

■ store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

■ use by expiration date on package

**Compare to the active ingredient in Low Dose BAYER®

**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered

trademark Bayer® Low Dose.

Distributed by

Major Pharmaceuticals

31778 Enterprise Drive,

Livonia, MI 48150 USA

  ASPIR LOW™

LOW STRENGTH 81mg ASPIRIN (NSAID)

Enteric Coated

1 1/4 gr. (81 mg) each Analgesic

SEE NEW WARNINGS INFORMATION

NEW Tablet Appearance

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

MAJOR®

ASPIR LOW (ASPIRIN) TABLET

Aspir Low

Aspir Low

Aspirin TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50436-0128(NDC:49483-390)
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
FERRIC OXIDE YELLOW
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
cellulose, microcrystalline
polysorbate 80
DIMETHICONE
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 NDC:50436-0128-1 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2011-05-24


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Be sure to consult your doctor before taking any medication!
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