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:
America Medic & Science, LLC
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 release action, this product will not provide fast relief of headaches or other sypmtoms needing immediate relief. Do not use if you are allergic to aspirin or any other pain reliever/ fever reducer. Stop use and ask 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 - redness or swelling is present - new symptoms occur - ringing in the ears or a loss of hearing occurs Do not use this product if printed safety seal under cap is torn or missing.
Authorization status:
OTC monograph final
Authorization number:
49638-115-60

ASPIRIN- aspirin tablet, delayed release

America Medic & Science, 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.

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Aspirin Delayed Release Tablets USP, 81 MG

Low Dose

Safety Coated Aspirin

Aspirin Delayed Release Tablets, USP 81 MG

Low Dose

Safety Coated Aspirin

Drug Facts

Active Ingredient

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 release action, this product will not provide fast relief of headaches or other sypmtoms

needing immediate relief.

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:

facial swelling

asthma (wheezing)

shock

hives

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 your doctor before use

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, kidney disease or asthma

you are taking a diuretic

Ask your doctor or pharmacist before use if you are taking a prescription drug for

gout

diabetes

arthritis

Stop use and ask 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

redness or swelling is present

new symptoms occur

ringing in the ears or a 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 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.

Do not use this product if printed safety seal under cap is torn or missing.

Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin an

aspirin regimen.

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

save carton for full directions and warnings

store at room temperature

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C Yellow # 10 al lake, FD&C Yellow # 6 al lake,

methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, triethyl

citrate

Questions or comments?

call 1-855-314-1850

Aspirin Delayed Release Tablets, USP 81 MG

ASPIRIN

aspirin tablet, delayed release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 6 38 -115

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

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

METHACRYLIC ACID (UNII: 1CS0 2G8 6 56 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

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

ye llo w

S core

no sco re

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 6 38 -115-6 0

1 in 1 CARTON

0 7/0 6 /20 20

1

6 0 in 1 BOTTLE; 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 final

pa rt343

0 7/0 6 /20 20

Labeler -

America Medic & Science, LLC (071065464)

Registrant -

America Medic & Science, LLC (071065464)

America Medic & Science, LLC

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Elvi Pharma LLC

0 78 739 246

ma nufa c ture (49 6 38 -115)

Revised: 9/2020

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