OTC Medication Information: Aspirin

ASPIRIN- aspirin tablet, film coated
Preferred Pharmaceuticals 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

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 have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

you have asthma
you are taking a diuretic
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

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 gets worse or lasts more than 3 days
new symptoms occur
ringing in the ears or a loss of hearing occurs

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 20°-25°C (68°-77°F)

Inactive ingredients

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

Questions or comments?

1-800-616-2471

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Compare to Bayer® Aspirin active ingredient

ADULT

ASPIRIN

Pain Reliever/Fever Reducer (NSAID)

Safe Pain Relief Plus Lifesaving Benefits

Talk to your doctor or other healthcare provider before using this product for your heart.

325 mg each

TEMPORARILY RELIEVES HEADACHES AND EVERYDAY ACHES & PAINS

Asprin Tablets 325mg
(click image for full-size original)
ASPIRIN
aspirin tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7582(NDC:0904-6809)
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSE, UNSPECIFIED
TALC
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 14mm
Flavor Imprint Code Aspirin;L
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7582-2 20 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68788-7582-1 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 03/11/2020
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-7582)

Revised: 03/2020 Preferred Pharmaceuticals Inc.

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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