ADULT LOW DOSE ENTERIC COATED ASPIRIN- 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:
REMEDYREPACK INC.
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
Authorization status:
OTC monograph final
Authorization number:
70518-2069-0

ADULT LOW DOSE ENTERIC COATED ASPIRIN- aspirin tablet, delayed release

REMEDYREPACK INC.

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.

----------

GC985

Active ingredient (in each tablet)

Aspirin 81 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 your 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 4-8 tablets every 4 hours, as needed, not more than 48

tablets in 24 hours, or as directed by a doctor

children under 12 years: ask a doctor

Other information

store at controlled room temperature

Inactive ingredients

anhydrous lactose, black iron oxide, brown iron oxide, colloidal silicon dioxide, croscarmellose

sodium, D&C yellow #10 aluminum

lake, hypromellose, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, mineral

oil, polysorbate 80, potassium hydroxide, propylene glycol, shellac, simethicone, sodium hydroxide,

sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

DRUG: Adult Low Dose Enteric Coated Aspirin

GENERIC: Aspirin

DOSAGE: TABLET, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-2069-0

COLOR: yellow

SHAPE: ROUND

SCORE: No score

SIZE: 7 mm

IMPRINT: T81

PACKAGING: 90 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

ASPIRIN 81mg in 1

INACTIVE INGREDIENT(S):

ANHYDROUS LACTOSE

DIMETHICONE

SHELLAC

PROPYLENE GLYCOL

SODIUM LAURYL SULFATE

BROWN IRON OXIDE

CELLULOSE, MICROCRYSTALLINE

TALC

TITANIUM DIOXIDE

TRIETHYL CITRATE

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A

HYPROMELLOSES

POTASSIUM HYDROXIDE

POLYSORBATE 80

CROSCARMELLOSE SODIUM

SODIUM HYDROXIDE

D&C YELLOW NO. 10

MINERAL OIL

SILICON DIOXIDE

FERROSOFERRIC OXIDE

STARCH, CORN

ADULT LOW DOSE ENTERIC COATED ASPIRIN

aspirin tablet, delayed release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 518 -20 6 9 (NDC:578 9 6 -9 8 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

8 1 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

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

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

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

MINERAL O IL (UNII: T5L8 T28 FGP)

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

STARCH, CO RN (UNII: O8 232NY3SJ)

REMEDYREPACK INC.

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

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

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

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

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

SHELLAC (UNII: 46 N10 7B71O)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

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)

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Product Characteristics

Color

ye llo w

S core

no sco re

S hap e

ROUND

S iz e

Flavor

Imprint Code

T8 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:70 518 -20 6 9 -

9 0 in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 5/0 8 /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 final

pa rt343

0 5/0 8 /20 19

Labeler -

REMEDYREPACK INC. (829572556)

Revised: 5/2019

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