ASPIRIN ENTERIC SAFETY COATED- aspirin tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Available from:
Publix Supermarkets, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever  - for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. - ask your doctor about other uses for safety coated 81 mg aspirin
Authorization status:
OTC monograph final
Authorization number:
56062-867-12

ASPIRIN ENTERIC SAFETY COATED- aspirin tablet

Publix Supermarkets, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpos e

Pain reliever

Us es

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of

its delayed action, this product will not provide fast relief of headaches or other symptoms

needing immediate relief.

ask your doctor about other uses for safety coated 81 mg aspirin

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 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

if you have ever had an allergic reaction to this product or any of its ingredients

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 a doctor or pharmacist before use if you are

taking a prescription drug for

gout

diabetes

arthritis

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away

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

ringing in the ears or loss of hearing occurs

new symptoms occur

These could be signs of a serious condition.

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

Other information

store between 59-86ºF (15-30ºC)

Inactive ingredients

D&C yellow #10, FD&C yellow #6**, methacrylic acid copolymer, microcrystalline cellulose,

pregelatinized starch corn, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc,

titanium dioxide, triethyl citrate

Principal Display Panel

†Compare to the active ingredient in Bayer® Low Dose Aspirin

LOW DOSE

As pirin

ASPIRIN REGIMEN 81 mg≠

PAIN RELIEVER (NSAID)

Safety coated≠≠

TABLETS

†This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Bayer® Low

Dose Aspirin

≠Talk to your doctor or other healthcare provider before using this product for your heart. Aspirin is

not right for everyone.

≠≠Coating helps protect against stomach upset

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN

OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY PUBLIX SUPERMARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY,

LAKELAND, FL 33811 1-888-267-3037

publix.com

Product Label

PUBLIX Low Dose Aspirin

ASPIRIN ENTERIC SAFETY COATED

aspirin tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:56 0 6 2-8 6 7

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

8 1 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

METHACRYLIC ACID - METHYL METHACRYLATE CO PO LYMER ( 1:1) (UNII: 74G4R6 TH13)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

Product Characteristics

Color

YELLOW

S core

no sco re

S hap e

ROUND

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:56 0 6 2-8 6 7-

1 in 1 BOX

0 7/31/20 19

1

120 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Publix Supermarkets, Inc.

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt343

0 7/31/20 19

Labeler -

Publix Supermarkets, Inc. (006922009)

Revised: 8/2019

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