ASPIR LOW- aspirin tablet

Aspir Low by

Drug Labeling and Warnings

Aspir Low by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. 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 flulike

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

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

 ASPIR LOW™

LOW STRENGTH 81mg ASPIRIN (NSAID)

Enteric Coated

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

SEE NEWWARNINGS INFORMATION

NEWTablet Appearance

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

MAJOR®

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Package/Label Principal Display Panel

Aspir Low

1 1/4 gr. (81 mg) (NSAID)

Enteric Coated Tablets

INGREDIENTS AND APPEARANCE

ASPIR LOW 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63187-913(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)

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: 63187-913-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2017
2	NDC: 63187-913-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2017
3	NDC: 63187-913-72	120 in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2017

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

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	REPACK(63187-913) , RELABEL(63187-913)