OTC Medication Information: Aspirin

ASPIRIN- aspirin tablet, film coated
Topco Associates, LLC

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.

Active ingredient (in each tablet)

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

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves:

  • minor pain of arthritis
  • headache
  • muscle pain
  • menstrual pain
  • toothache
  • pain and fever of colds

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.

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

  • 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 unless directed by a doctor

  • children under 12 years: do not use unless directed by a doctor

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, propylene glycol

Questions or comments?

1-888-423-0139

Principal display panel

TopCare®
health™

NDC 36800-157-12

COMPARE TO GENUINE BAYER® ASPIRIN
ACTIVE INGREDIENT

REGULAR STRENGTH
Aspirin
325 mg
PAIN RELIEVER • FEVER REDUCER
(NSAID)

•Safe Pain Relief
•Sodium & Caffeine Free

100 COATED TABLETS

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

This product is not manufactured or distributed by Bayer AG, owner of
the registered trademark Genuine Bayer® Aspirin. 50844 REV0318B15712

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0521 QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com

Visit here for more information: http://topbrnds.com/48ZZSQ

TopCare 44-157
(click image for full-size original)

TopCare 44-157

ASPIRIN aspirin tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-157
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 44;157;ASPIRIN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-157-12 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:36800-157-87 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (36800-157-87)
3 NDC:36800-157-17 300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:36800-157-14 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 02/10/1996
Labeler — Topco Associates, LLC (006935977)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (36800-157)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (36800-157)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 pack (36800-157)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (36800-157)

Revised: 09/2021 Topco Associates, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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