ASPIRIN- aspirin tablet
Geri-Care Pharmaceuticals, Corp

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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Health Star 44-249-Delisted

Active ingredient

Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

headache
muscular aches
minor pain of arthritis
backache
the common cold
toothache
premenstrual and menstrual cramps

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
shock
hives
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
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have had stomach ulcers or bleeding problems
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 are taking a diuretic
you have high blood pressure, heart disease, liver cirrhosis or kidney disease

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
an allergic reaction occurs. Seek medical help right away.
new symptoms occur
ringing in the ears or loss of hearing occurs
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present

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 (1-800-222-1222) right away.

Directions

drink a full glass of water with each dose
adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
children under 12 years: do not use unless directed by a doctor

Other information

use by expiration date on package
store at 25º C (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

corn starch

Questions or comments?

1-800-540-3765

Principal Display Panel

NDC 57896-901-25

HEALTH ★STAR
THE SENSIBLE CHOICE
FOR PRICE AND HEALTH

ASPIRIN
(NSAID) 325 mg

Fast, Safe, Effective
Pain Relief

COMPARE TO THE ACTIVE INGREDIENT OF BAYER® ASPIRIN**

250 Tablets

**This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Aspirin.
50844 ORG011324913

DISTRIBUTED BY:
GERI-CARE PHARMACEUTICAL CORP.
1650 63 Street, Brooklyn NY 11204

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

Health Star 44-249

ASPIRIN
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57896-109
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;249
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57896-109-25	250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/04/1993	12/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part343	08/04/1993	12/30/2018

Labeler - Geri-Care Pharmaceuticals, Corp (611196254)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(57896-109)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(57896-109)

Revised: 9/2017

Document Id: 84ae6e32-7c89-4d54-b722-501d8ddda61e

Set id: 78e4f316-ed19-400c-8ad3-5105b88d8176

Version: 6

Effective Time: 20170920

Geri-Care Pharmaceuticals, Corp