Medication Guide App

Berkley and Jensen Aspirin

Dosage form: tablet
Ingredients: ASPIRIN 325mg
Labeler: BJWC
NDC Code: 68391-416

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.

BJWC Aspirin Drug Facts

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID*)

*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
shock
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
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 have ever had an allergic reaction to 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

diabetes
gout
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 for more than 10 days
fever lasts for more than 3 days
ringing in the ears or loss of hearing occurs
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. (1-800-222-1222)

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
store at 20º-25ºC (68º-77ºF)

Inactive ingredients

corn starch, dibasic calcium phosphate dihydrate, hypromellose, talc, triacetin

Questions or comments?

1-800-934-1204

Principal Display Panel

PAIN RELIEVER/FEVER REDUCER

ASPIRIN

FOR ADULTS

PAIN RELIEVER/FEVER REDUCER (NSAID)

SAFE PAIN RELIEF PLUS LIFESAVING BENEFITS

FAST, SAFE PAIN RELIEF OF:

Headaches – Everyday Aches & Pains

Compare to the active ingredient of Bayer® Aspirin

500 COATED TABLETS

325 mg EACH

GLUTEN FREE

BERKLEY AND JENSEN ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-416
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
TRIACETIN 
HYPROMELLOSES 
TALC 
STARCH, CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize14mm
FlavorImprint CodeAspirin;L
Contains    
Packaging
#Item CodePackage Description
1NDC:68391-416-90500 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/23/2008
Labeler - BJWC (159082692)

Revised: 01/2014
 
BJWC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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