OTC Medication Information: Aspirin
ASPIRIN- aspirin tablet, film coated
Rugby Laboratories
Active ingredient (in each tablet)
Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
temporarily relieves:
- headache
- pain and fever of colds
- toothache
- menstrual pain
- muscle pain
- 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:
- shock
- facial swelling
- hives
- 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 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 asthma
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- 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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- 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 at 20 weeks or later in 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
- do not take more than directed
- 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 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
corn starch, hypromellose, polyethylene glycol, propylene glycol
Questions or comments?
1-800-645-2158
Principal Display Panel
Rugby®
NDC 0536-1054-29
† Compare to the active ingredient in
Genuine Bayer® Aspirin
Aspirin
325 mg
Pain Reliever / Fever Reducer
(NSAID)
Safe Pain Relief
Actual size
100 Tablets
† This product is not manufactured or distributed by Bayer AG, owner of the registered trademark Genuine Bayer® Aspirin.
50844 REV0122D15712
Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL AROUND CAP IS BROKEN OR MISSING
Rev. 09/20 R-17 Re-order No. 370397
Rugby 44-157
ASPIRIN aspirin tablet, film coated | |||||||||||||||||||||
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Labeler — Rugby Laboratories (079246066) |
Establishment | |||
Name | Address | ID/FEI | Operations |
LNK International, Inc. | 038154464 | pack (0536-1054) |
Establishment | |||
Name | Address | ID/FEI | Operations |
LNK International, Inc. | 832867837 | manufacture (0536-1054) |
Establishment | |||
Name | Address | ID/FEI | Operations |
LNK International, Inc. | 832867894 | manufacture (0536-1054) |
Establishment | |||
Name | Address | ID/FEI | Operations |
LNK International, Inc. | 868734088 | manufacture (0536-1054) |
Establishment | |||
Name | Address | ID/FEI | Operations |
LNK International, Inc. | 967626305 | pack (0536-1054) |
Revised: 03/2024 Rugby Laboratories
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.