HANDY SOLUTIONS GENUINE ASPIRIN BAYER- aspirin tablet

Handy Solutions GENUINE ASPIRIN BAYER by

Drug Labeling and Warnings

Handy Solutions GENUINE ASPIRIN BAYER by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc., Bayer HealthCare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Handy Solutions GENUINE ASPIRIN BAYER

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

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
• you have a sodium-restricted diet

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

• each tablet contains: sodium 47 mg
• store at room temperature. Avoid excessive heat and moisture. Keep desiccant and product in original bottle. Immediately close cap tightly after use.
• save carton for full directions and warnings

Inactive ingredients

carnauba wax, colloidal silicon dioxide, hypromellose, sodium carbonate, zinc stearate

Questions or comments?

1-800-331-4536 (Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.com

Handy Solutions GENUINE ASPIRIN BAYER 4 Tablets (

67751-009-01) | Handy Solutions GENUINE ASPIRIN BAYER 2 Tablets (67751-009-02)

INGREDIENTS AND APPEARANCE

HANDY SOLUTIONS GENUINE ASPIRIN BAYER 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-009
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
Carnauba Wax (UNII: R12CBM0EIZ)	5.00 mg
Silicon Dioxide (UNII: ETJ7Z6XBU4)	8.50 mg
Hypromelloses (UNII: 3NXW29V3WO)	16.00 mg
Sodium carbonate (UNII: 45P3261C7T)	25.00 mg
Zinc stearate (UNII: H92E6QA4FV)	4.61 mg

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	BA;325
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-009-01	1 in 1 BLISTER PACK
1		4 in 1 POUCH
2	NDC: 67751-009-02	1 in 1 BLISTER PACK
2		2 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	08/21/2013

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Bayer HealthCare LLC		127769128	manufacture(67751-009)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		091917799	repack(67751-009) , relabel(67751-009)