OTC Medication Information: Bayer Genuine Aspirin

BAYER GENUINE ASPIRIN- aspirin tablet
Navajo Manufacturing Company 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.

Drug Facts

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID) 1

---

1

nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves

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

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:

• hives
• facial swelling
• asthma (wheezing)
• shock

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

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

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 are taking a diuretic
• 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
• pain gets worse or lasts more than 10 days
• redness or swelling is present
• fever lasts more than 3 days
• new symptoms occur
• ringing in the ears or a loss of hearing occurs

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
• children under 12 years: consult a doctor

Other information

• save carton for full directions and warnings
• store at room temperature

Inactive ingredients

corn starch, hypromellose, powdered cellulose, triacetin

Questions or comments?

1-800-331-4536

(Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.com

PRINCIPAL DISPLAY PANEL

BAYER GENUINE ASPIRIN aspirin tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-129(NDC:0280-2000) 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 HYPROMELLOSES POWDERED CELLULOSE TRIACETIN

Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code BAYER Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67751-129-01 1 POUCH in 1 CARTON contains a POUCH 1 2 TABLET in 1 POUCH This package is contained within the CARTON (67751-129-01) 2 NDC:67751-129-02 2 POUCH in 1 CARTON contains a POUCH 2 2 TABLET in 1 POUCH This package is contained within the CARTON (67751-129-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 06/01/2016

Labeler — Navajo Manufacturing Company Inc. (091917799)

Registrant — Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Operations
Navajo Manufacturing Company Inc.		136941411	relabel (67751-129), repack (67751-129)

Revised: 03/2023 Navajo Manufacturing Company Inc.