ASPIRIN 81 MG- aspirin tablet, chewable

Aspirin 81 mg by

Drug Labeling and Warnings

Aspirin 81 mg by is a Otc medication manufactured, distributed, or labeled by Reliable 1 Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drugs Facts

Active ingredients (in each tablet)

Aspirin USP 81 mg (NSAID)*

*nonsterodial anti-inflammatory drug

Purpose

Pain reliever

Uses

• temporarily relieaves 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

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 symptoms chould be an early sign of Reye's syndrome, a rare but serious illness.

SPL UNCLASSIFIED SECTION

Allergy alert: Aspirin may cause a severe allergic reastion which may include:

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

SPL UNCLASSIFIED SECTION

Stomach bleeding warning: This product contains an NSID, 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 steriod drug
• take other drugs containing prescription or non-prescription NSAIDs (ibuprofen, naproxen, or others)
• take more or for a longer time than directed
• have 3 or more alcoholic drinks every day while using this product

Drug Facts continued on back of label

DO NOT USE

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• for at least 7 days after tonsillectomy or oral surgery

ASK DOCTOR

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

ASK DOCTOR/PHARMACIST

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

Stop use and ask a doctor if

• you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • 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 loss of hearing occurs

These could be sings of a serious condition

KEEP OUT OF REACH OF CHILDREN

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

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE

• adults and children 12 years & older: take 4 to 8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours
• children under 12 years: ask a doctor

Other infomation

• Store at room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

compressible sugar, corn starch, FD&C yellow #6 alum. lake, magnesium stearate, orange flavor, silicon dioxide

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BAYER®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

PRINCIPAL DISPLAY PANEL

NDC: 69618-014-36

ORANGE FLAVORED

Aspirin USP 81 mg (NSAID)

Adult Low Strength

PAIN RELIEVER

36 CHEWABLE TABLETS

*Compare to Active Ingredient in Aspirin Regimen BAYER® Chewable

INGREDIENTS AND APPEARANCE

ASPIRIN 81 MG 
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-014
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
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCROSE (UNII: C151H8M554)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	8mm
Flavor	ORANGE	Imprint Code	AP;009
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-014-36	36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	11/01/2015

Labeler - Reliable 1 Laboratories LLC (079718111)