ASPIRIN 81 MG ENTERIC COATED- aspirin tablet

Aspirin 81 mg Enteric Coated by

Drug Labeling and Warnings

Aspirin 81 mg Enteric Coated 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

Drug Facts

Active ingredient (in each tablet)

Aspirin USP, 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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 you 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 comiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

OTHER SAFETY INFORMATION

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

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

SPL UNCLASSIFIED SECTION

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 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

DO NOT USE

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

Drug Facts continued on back of label

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 s

STOP USE

Stop use and ask a doctor if

• you experience any of the following signs of stomach bleeding:
• feel faint
• 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 ear or loss of hearing occurs

these could be sings of a serious condition

PREGNANCY OR BREAST FEEDING

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 complictions during delivery.

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.

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 information

• store at room temperature 15°-30°C (59°-86°F)

INACTIVE INGREDIENT

croscarmellose sodium, D&C yellow #10 (Al-lake), HPMC, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, povidone, silicon dioxide, sodium lauryl sulfate, corn strach, stearic acid, talc, titanium dioxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC: 69618-017-02

Enteric Coated

Aspirin USP 81 mg (NSAID)

Adult Low Strength

PAIN RELIEVER

120 TABLETS

*Compare to Active Ingredient in Aspirin Regimen BAYER®

INGREDIENTS AND APPEARANCE

ASPIRIN 81 MG ENTERIC COATED 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-017
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
METHACRYLIC ACID (UNII: 1CS02G8656)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	AP;121
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-017-02	120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2015
2	NDC: 69618-017-10	1000 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)