REGULAR STRENGTH ENTERIC COATED ASPIRIN- aspirin tablet, coated

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

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Active ingredient:
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Available from:
A-S Medication Solutions
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever - for the temporary relief of minor aches and pains - ask your doctor about other uses for aspirin
Product summary:
Product: 50090-4462 NDC: 50090-4462-1 30 TABLET, COATED in a BOTTLE NDC: 50090-4462-3 100 TABLET, COATED in a BOTTLE NDC: 50090-4462-5 90 TABLET, COATED in a BOTTLE
Authorization status:
OTC monograph not final
Authorization number:
50090-4462-1, 50090-4462-3, 50090-4462-5

REGULAR STRENGTH ENTERIC COATED ASPIRIN- aspirin tablet, coated

A-S Medication Solutions

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.

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Active ingredient (in each tablet)

Aspirin 325 mg(NSAID)*

*nonsteroidal anti-inflammatory drug

Purpos e

Pain reliever

Us es

for the temporary relief of minor aches and pains

ask your doctor about other uses for 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

asthma (wheezing)

shock

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

the stomach bleeding warning applies to you

you are taking a diuretic

you have a history of stomach problems, such as heartburn

you have: -high blood pressure -heart disease -liver cirrhosis -kidney disease -asthma

Ask a doctor or pharmacist before use if you are

taking any other drug containing an NSAID (prescription or nonprescription)

taking a blood thinning (anticoagulant) or steroid drug

taking a prescription drug for diabetes, gout or arthritis

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

an allergic reaction occurs. Seek medical help right away

pain gets worse or lasts more than 10 days

redness or swelling is present

fever gets worse or lasts more than 3 days

any new symptoms occur

ringing in the ears or 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.

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

swallow whole, do not chew or crush

do not exceed recommended dose

adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12

tablets in 24 hours, or as directed by a doctor

children under 12 years: ask a doctor

Other information

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

for institutional use only

Inactive ingredients

cellulose, D&C yellow

#10 lake, FD&C yellow #6 lake, hypromellose, iron

oxide, PEG, polydextrose, polyvinyl acetate phthalate,

propylene glycol, shellac wax, silica, simethicone,

sodium alginate, sodium bicarbonate, starch, stearic

acid, talc, titanium dioxide, triacetin, triethyl citrate.

May also contain acetylated monoglycerides,

croscarmellose sodium, hypromellose phthalate,

methacrylic acid, mineral oil, polysorbate 80, sodium

lauryl sulfate.

HOW SUPPLIED

Product: 50090-4462

NDC: 50090-4462-1 30 TABLET, COATED in a BOTTLE

NDC: 50090-4462-3 100 TABLET, COATED in a BOTTLE

NDC: 50090-4462-5 90 TABLET, COATED in a BOTTLE

As pirin

REGULAR STRENGTH ENTERIC COATED ASPIRIN

aspirin tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 0 9 0 -446 2(NDC:578 9 6 -9 21)

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

325 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

STARCH, CO RN (UNII: O8 232NY3SJ)

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

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

HYPRO MELLO SE, UNSPECIFIED (UNII: 3NXW29 V3WO)

PO LYVINYL ACETATE PHTHALATE (UNII: 58 QVG8 5GW3)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYDEXTRO SE (UNII: VH2XOU12IE)

A-S Medication Solutions

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SHELLAC (UNII: 46 N10 7B71O)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

SO DIUM ALGINATE (UNII: C26 9 C4G2ZQ)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

Product Characteristics

Color

o ra nge

S core

no sco re

S hap e

ROUND

S iz e

9 mm

Flavor

Imprint Code

44;227

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 0 9 0 -446 2-1

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /12/20 19

2

NDC:50 0 9 0 -446 2-3

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /12/20 19

3

NDC:50 0 9 0 -446 2-5

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /12/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 7/0 1/20 0 0

Labeler -

A-S Medication Solutions (830016429)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

A-S Medicatio n So lutio ns

8 30 0 16 429

RELABEL(50 0 9 0 -446 2) , REPACK(50 0 9 0 -446 2)

Revised: 8/2019

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