Label: ASPIRIN tablet, film coated
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- NDC Code(s): 50844-157-12
- Packager: L.N.K. International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated September 9, 2022
If you are a consumer or patient please visit this version.
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- Active ingredient (in each tablet)
- Purpose
- Uses
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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
- have 3 or more alcoholic drinks every day while using this product
- have had stomach ulcers or bleeding problems
- take more or for a longer time than directed
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
Do not use
- if you are allergic to aspirin or any other pain reliever/fever reducer
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if
- you are taking a diuretic
- 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
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
- 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
- ringing in the ears or a 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
- new symptoms occur
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
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Principal display panel
QUALITY
+PLUSNDC 50844-157-12
†Compare to the
active ingredient in
Genuine Bayer® AspirinASPIRIN
PAIN RELIEVER/
FEVER REDUCER
(NSAID)325 mg
100
Tablets
Talk to your doctor
or other healthcare
provider before
using this product
for your heart.ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING†This product is not manufactured or distributed by Bayer
HealthCare LLC, owner of the registered trademark Genuine
Bayer® Aspirin.
50844 REV0318B15712Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
44-157
-
INGREDIENTS AND APPEARANCE
ASPIRIN
aspirin tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-157 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code ASPIRIN;44;157 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50844-157-12 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/10/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 02/10/1996 Labeler - L.N.K. International, Inc. (038154464) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(50844-157) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(50844-157) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(50844-157) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(50844-157) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(50844-157)