ADULT LOW DOSE- aspirin 81 mg 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:
Safrel Pharmaceuticals, LLC.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
- 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 81 mg Aspirin
Authorization status:
OTC monograph final
Authorization number:
71309-003-01, 71309-003-02, 71309-003-25, 71309-003-30, 71309-003-50, 71309-003-60, 71309-003-65

ADULT LOW DOSE- aspirin 81 mg tablet, delayed release

Safrel Pharmaceuticals, 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.

----------

Pain Reliever - Aspirin Delayed Release Tablets, 81 mg

Drug Facts

Active Ingredients (in each tablet) Purpose

Aspirin 81 mg (NSAID)* ........................................ Pain reliever

*nonsteroidal anti-inflammatory drug

Us es

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 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

shock

facial swelling

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

Ask a doctor before use if

you have asthma

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

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

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

an allergic reaction occurs.

Seek medical help right away.

ringing in the ears or loss of hearing occurs

pain gets worse or lasts for more than 10 days

fever gets worse or lasts for more than 3 days

redness or swelling present in the painful area

new symptoms occur

These could be sign 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.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs

or symptoms.

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 at room temperature 15-30ºC (59-86ºF)

read all product information before using.

Keep this box for important information

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

BROKEN OR MISSING

Inactive ingredients

Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow

#10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro

crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc,

titanium dioxide, triethyl citrate

Questions or comments?

Call toll free 1-844-384-3723 Monday through Friday 9AM – 5PM EST or www.safrelpharma.com

PRINCIPAL DISPLAY PANEL

See New Warnings Information & Directions

Compare to Bayer® Low Dose Aspirin active ingredients†

† This product is not manufactured or distributed by Bayer HealthCare LLC., owner of the registered

trademark Bayer® Low Dose Aspirin.

Aspirin Delayed Release Tablets, 81 mg

ADULT LOW DOSE

aspirin 81 mg tablet, delayed release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7130 9 -0 0 3

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

CARNAUBA WAX (UNII: R12CBM0 EIZ)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

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 )

BRO WN IRO N O XIDE (UNII: 1N0 32N7MFO)

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

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

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)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TALC (UNII: 7SEV7J4R1U)

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

Safrel Pharmaceuticals, LLC.

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7130 9 -0 0 3-25

25 in 1 BOX

0 6 /0 5/20 17

1

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:7130 9 -0 0 3-50

50 in 1 BOX

0 6 /0 5/20 17

2

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:7130 9 -0 0 3-0 2

2 in 1 POUCH

0 6 /0 5/20 17

3

2 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

4

NDC:7130 9 -0 0 3-0 1

10 0 0 in 1 BOTTLE

0 6 /0 5/20 17

4

NDC:7130 9 -0 0 3-6 5

36 5 in 1 BOTTLE

4

NDC:7130 9 -0 0 3-30

30 in 1 BOTTLE

4

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

5

NDC:7130 9 -0 0 3-6 0

1 in 1 CARTON

0 6 /0 5/20 17

5

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 2/0 9 /20 16

Labeler -

Safrel Pharmaceuticals, LLC. (080566287)

Revised: 1/2020

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