ASPIR LOW- aspirin tablet

Aspir Low by

Drug Labeling and Warnings

Aspir Low by is a Otc medication manufactured, distributed, or labeled by NCS HealthCare of KY, Inc dba Vangard Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Keep Out of Reach of Children

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

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

Reyeʼs 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 ■ 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 ■ 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

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.

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, corn starch

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 BAYER® Low Dose

**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

M-14    Rev. 08/15          

 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®

Package/Label Principal Display Panel

 

INGREDIENTS AND APPEARANCE

ASPIR LOW 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0615-8051(NDC: 0904-7704)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
STARCH, CORN (UNII: O8232NY3SJ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	HEART
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-8051-30	6 in 1 BOX, UNIT-DOSE
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0615-8051-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	05/24/2011

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL(0615-8051) , REPACK(0615-8051)