LOW DOSE ASPIRIN - aspirin tablet, chewable

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

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Active ingredient:
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Available from:
A-S Medication Solutions
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.  - ask your doctor about other uses for this product.
Product summary:
Product: 50090-0909 NDC: 50090-0909-0 36 TABLET, CHEWABLE in a BOTTLE
Authorization status:
OTC monograph final
Authorization number:
50090-0909-0

LOW DOSE ASPIRIN - aspirin tablet, chewable

A-S Medication Solutions

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.

----------

Drug Facts

Active Ingredient (in each tablet):

Aspirin 81mg (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.

ask your doctor about other uses for this product.

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like

symptoms should not use this products. 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

asthma (wheezing)

facial swelling

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 you are allergic to aspirin or any other pain reliever/fever reducer

this product for at least 7 days after tonsilectomy or oral surgery unless directed by a doctor

Ask a doctor before use if

the 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 have asthma

you are taking a diuretic

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

gout

diabetes

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

allergic reaction occurs

pain gets worse or lasts more than 10 days

redness or swelling is present

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 accidental 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

Other information

Tamper Evident: Do not use if safety seal under cap is broken or missing

store at room temperature (15°-30°C)

avoid excess heat and moisture

Inactive ingredients

Corn starch, dextrose monohydrate, FD&C yellow #6, flavor, silicon dioxide, sodium saccharine and

stearic acid

Ques tions ?

Adverse drug event call: (866) 562-2756

HOW SUPPLIED

Product: 50090-0909

NDC: 50090-0909-0 36 TABLET, CHEWABLE in a BOTTLE

As pirin

LOW DOSE ASPIRIN

aspirin tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 0 9 0 -0 9 0 9 (NDC:16 10 3-36 6 )

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

DEXTRO SE MO NO HYDRATE (UNII: LX22YL0 8 3G)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

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

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

o ra nge

S core

no sco re

S hap e

ROUND

S iz e

8 mm

Flavor

Imprint Code

PH0 34

A-S Medication Solutions

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 0 9 0 -0 9 0 9 -0

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

11/28 /20 14

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 8 /22/20 0 7

Labeler -

A-S Medication Solutions (830016429)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

A-S Medicatio n So lutio ns

8 30 0 16 429

RELABEL(50 0 9 0 -0 9 0 9 ) , REPACK(50 0 9 0 -0 9 0 9 )

Revised: 3/2019

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