ASPIRIN LOW DOSE ENTERIC COATED- 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:
Medical Purchasing Solutions, LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
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. Do not use if your are allergic to aspirin or any other pain relieiver/fever reducer 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 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
Product summary:
Product: 63739-522 NDC: 63739-522-10 10 TABLET, COATED in a BLISTER PACK NDC: 63739-522-01 30 TABLET, COATED in a BLISTER PACK
Authorization status:
OTC monograph not final
Authorization number:
71872-7154-1

ASPIRIN LOW DOSE ENTERIC COATED- aspirin tablet, coated

Medical Purchasing Solutions, LLC

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.

----------

Active Ingredient in Each tablet

Aspirin 81 mg (NSAID) Non-steroidal anti-inflammatory drug

Ask a doctor before use if: stomach bleeding waring 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, hou have lost a

lot of fluid due to vomiting or diarhea

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.

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 reactino which may include:

hives, facial swelling, shock, asthma(wheezingStomach bleeding warning: This product contains an

NSAID which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older,

hae had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take

other drugs containing prescription or non prescription 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.

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

Do not use if your are allergic to aspirin or any other pain relieiver/fever reducer

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

If pregnant or breast-feeding, ask a health profession 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 the 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 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,

itianium dioxide

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

HOW SUPPLIED

Product: 63739-522

NDC: 63739-522-10 10 TABLET, COATED in a BLISTER PACK

NDC: 63739-522-01 30 TABLET, COATED in a BLISTER PACK

Principal Display Panel - Outer Package

ASPIRIN LOW DOSE ENTERIC COATED

aspirin tablet, coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:718 72-7154(NDC:6 3739 -522)

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

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

IRO N (UNII: E1UOL152H7)

METHACRYLIC ACID - ETHYL ACRYLATE CO PO LYMER ( 1:1) TYPE A (UNII: NX76 LV5T8 J)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

Product Characteristics

Color

ye llo w

S core

no sco re

S hap e

ROUND

S iz e

Flavor

Imprint Code

e mbo sse d;uppe r;he a rt;lo we r;pla in

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:718 72-7154-1 1 in 1 BAG

0 2/21/20 19

1

4 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

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 6 /28 /20 10

Labeler -

Medical Purchasing Solutions, LLC (601458529)

Medical Purchasing Solutions, LLC

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Medical Purchasing So lutio ns, LLC

6 0 1458 529

re pa c k(718 72-7154)

Revised: 4/2019

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