OTC Medication Information: Aspirin

ASPIRIN- aspirin tablet, coated
Amerisource Bergen

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

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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
  • asthma (wheezing)
  • hives
  • shock

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcoholic drinks every day while using this product
  • are age 60 or older
  • 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

  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

  • 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
  • you are taking a diuretic

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

  • new symptoms occur

  • pain gets worse or lasts more than 10 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 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)

  • see end flap for expiration date and lot number

Inactive ingredients

black iron oxide, cellulose, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391

Principal display panel

Compare to Ecotrin® active ingredient†

NDC 46122-596-02

REGULAR STRENGTH

Aspirin 325 mg
Pain Reliever (NSAID)

Enteric Coated

125 Tablets 325 mg Each

Actual Size

†This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Ecotrin®.

50844 ORG031822757

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

Distributed By
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
Questions or Concerns?www.mygnp.com

SATISFACTION GUARANTEED

GNP 44-227
(click image for full-size original)

GNP 44-227

ASPIRIN aspirin tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-596
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
FERROSOFERRIC OXIDE
SILICON DIOXIDE
STARCH, CORN
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C YELLOW NO. 6
HYPROMELLOSE, UNSPECIFIED
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SHELLAC
SODIUM ALGINATE
SODIUM BICARBONATE
STEARIC ACID
TALC
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE
WATER
DIMETHICONE
POWDERED CELLULOSE
Polyvinyl Acetate Phthalate
PROPYLENE GLYCOL
Product Characteristics
Color orange Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 44;227
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46122-596-02 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 125 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (46122-596-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 06/01/2019
Labeler — Amerisource Bergen (007914906)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (46122-596)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 manufacture (46122-596), pack (46122-596)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (46122-596)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (46122-596)

Revised: 04/2021 Amerisource Bergen

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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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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