Aspirin: Package Insert and Label Information

ASPIRIN- aspirin tablet
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

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:

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

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 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
  • take a blood thinning (anticoagulant) or steroid drug
  • have had stomach ulcers or bleeding problems

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 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

  • 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 (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 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 ingredient

corn starch

Questions or comments?

Call 1-800-426-9391

Principal display panel

HEALTHCARE

NDC 64092-110-99

Aspirin 325 mg

Pain Reliever/Fever Reducer
(NSAID)

• Analgesic • No Caffeine
• For temporary
relief of minor
aches & pains

100 TABLETS

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


Distributed by: Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E. Grand Rapids, MI 49512
www.glwholesale.com

50844 REV0318B24912

Healthcare 44-249
(click image for full-size original)

Healthcare 44-249

ASPIRIN
aspirin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64092-110
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
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code ASPIRIN;44;249
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64092-110-99 100 TABLET 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 08/04/1993
Labeler — GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 MANUFACTURE (64092-110)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 PACK (64092-110)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK (64092-110)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 PACK (64092-110)

Revised: 06/2020 GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

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