ASPIRIN- aspirin tablet, film coated

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

Buy It Now

Active ingredient:
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Available from:
H E B
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer temporarily relieves
Authorization status:
OTC monograph not final
Authorization number:
37808-031-78, 37808-031-87, 37808-031-90

ASPIRIN- aspirin tablet, film coated

H E B

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.

----------

HEB Aspirin Drug Facts

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpos es

Pain reliever/fever reducer

Us es

temporarily relieves

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:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach

bleeding. The chance is higher if you

menstrual pain

headache

toothache

pain and fever of colds

minor pain of arthritis

muscle pain

hives

facial swelling

shock

asthma (wheezing)

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)

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

Stop use and ask a doctor if

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

have 3 or more alcoholic drinks every day while using this product

take more or for a longer time than directed

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

gout

diabetes

arthritis

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

fever gets worse or lasts more than 3 days

new symptoms occur

ringing in the ears or a loss of hearing occurs

drink a full glass of water with each dose

Inactive ingredients

corn starch, dibasic calcium phosphate dihydrate, hypromellose, talc, triacetin

Ques tions ?

1-800-719-9260

Principal Display Panel

Compare to Bayer

Genuine Aspirin active ingredient

For Adults

Aspirin 325 mg

Pain Reliever/Fever Reducer (NSAID)

Fast, Safe Pain Relief

Headaches - Everyday Aches & Pains

Safe Pain Relief Plus Lifesaving Benefits

Talk to your doctor or other healthcare provider before using this product for your heart.

actual size

100 COATED TABLETS

adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours,

not to exceed 12 tablets in 24 hours

children under 12 years: consult a doctor

ASPIRIN

aspirin tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:378 0 8 -0 31

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

H E B

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

TALC (UNII: 7SEV7J4R1U)

TRIACETIN (UNII: XHX3C3X6 73)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

14mm

Flavor

Imprint Code

Aspirin;L

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:378 0 8 -0 31-78

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /15/19 9 1

2

NDC:378 0 8 -0 31-8 7

30 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /25/20 0 1

3

NDC:378 0 8 -0 31-9 0

50 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/14/20 0 5

0 1/14/20 15

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 9 /15/19 9 1

Labeler -

H E B (007924756)

Revised: 4/2019

Similar products

Search alerts related to this product

View documents history

Share this information