ASPIRIN 325 MG- aspirin tablet, delayed release

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

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Active ingredient:
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Available from:
Strategic Sourcing Services LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever - for the temporary relief of minor aches and pains due to: headache muscle pain toothache menstrual pain colds minor pain of arthritis - headache - muscle pain - toothache - menstrual pain - colds - minor pain of arthritis - or as recommended by your doctor
Authorization status:
OTC monograph not final
Authorization number:
62011-0405-1

ASPIRIN 325 MG- aspirin tablet, delayed release

Strategic Sourcing Services 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.

----------

HMT-1081B-2019-0517

Drug Facts

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 due to:

headache

muscle pain

toothache

menstrual pain

colds

minor pain of arthritis

or as recommended by your doctor

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 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

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:

diabetes

gout

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 for more than 10 days

redness or swelling is present

fever gets worse or lasts for more than 3 days

new symptoms occur

ringing in the ears or loss of hearing occurs

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 right away (1-800-222-1222).

Directions

drink a full glass of water with each dose

adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last; do not

take more than 12 tablets in 24 hours unless directed by a doctor

children under 12 years: ask a doctor

Other information

store between 20-25°C (68-77°F) in a dry place

retain carton for complete product information and warnings

Inactive ingredients

corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake,

hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80,

simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

PRINCIPAL DISPLAY PANEL

HealthMart®

NDC 62011-0405-1

Compare to Ecotrin® Regular Strength active ingredient†

Regular Strength

Aspirin 325 mg

Pain Reliever (NSAID)

Safety Coated

Aspirin Regimen**

125 ENTERIC COATED TABLETS

ASPIRIN 325 MG

aspirin tablet, delayed release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 20 11-0 40 5

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

Strategic Sourcing Services LLC

STARCH, CO RN (UNII: O8 232NY3SJ)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

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

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

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

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

MINERAL O IL (UNII: T5L8 T28 FGP)

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

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

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

o ra nge

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:6 20 11-0 40 5-

1 in 1 CARTON

0 5/17/20 19

1

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

Pro duc t

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 5/17/20 19

Labeler -

Strategic Sourcing Services LLC (116956644)

Revised: 8/2019

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