FDA records indicate that there are no current recalls for this drug.
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Uncoated Aspirin Recall
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Side Effects & Adverse Reactions
Reye's syndrome: Children and teenagers who have or 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 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)
- take more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product
the stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have liver cirrhosis
- you have asthma
- you have high blood pressure
- you have heart or kidney disease
- you have taken a diuretic
- taking any other drug containing an NSAID (prescription or nonprescription)
- taking a blood thinning (anticoagulant) or steroid drug
- taking a prescription drug for diabetes, gout or arthritis
- 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
- an allergic reaction occurs. Seek medical help right away.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms occur
- ringing in the ears or loss of hearing occurs
Ask a doctor before use if
the stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have liver cirrhosis
- you have asthma
- you have high blood pressure
- you have heart or kidney disease
- you have taken a diuretic
- taking any other drug containing an NSAID (prescription or nonprescription)
- taking a blood thinning (anticoagulant) or steroid drug
- taking a prescription drug for diabetes, gout or arthritis
- 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
- an allergic reaction occurs. Seek medical help right away.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- any new symptoms occur
- ringing in the ears or loss of hearing occurs
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
provides temporary relief of
- headache
- pain and fever of colds
- muscle pain
- menstrual pain
- toothache
- minor pain of arthritis
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Uncoated Aspirin Manufacturers
-
Woonsocket Prescription Center,incorporated
Uncoated Aspirin | Lupin Pharmaceuticals, Inc.
2.1 Important Administration Instructions Cefuroxime axetil tablets USP and cefuroxime axetil for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis [see CLINICAL PHARMACOLOGY (12.3)] . Administer cefuroxime axetil tablets USP tablets as described in the appropriate dosage guidelines [see DOSAGE AND ADMINISTRATION (2.2)]. Administer cefuroxime axetil tablets USP with or without food. Pediatric patients (aged 13 years and older) who cannot swallow the cefuroxime axetil tablets USP whole should receive cefuroxime axetil for oral suspension because the tablet has a strong, persistent bitter taste when crushed [see DOSAGE AND ADMINISTRATION (2.2)]. 2.2 Dosage for cefuroxime axetil tablets USPAdminister cefuroxime axetil tablets USP as described in the dosage guidelines table below with or without food.
Table 1. Adult Patients and Pediatric Patients Dosage Guidelines for Cefuroxime Axetil Tablets USP Infection
Dosage
Duration (Days)
Adults and Adolescents (13 years and older)
Pharyngitis/tonsillitis (mild to moderate)
250 mg every 12 hours
10
Acute bacterial maxillary sinusitis (mild to moderate)
250 mg every 12 hours
10
Acute bacterial exacerbations of chronic bronchitis (mild to moderate)
250 or 500 mg every 12 hours
10a
Secondary bacterial infections of acute bronchitis
250 or 500 mg every 12 hours
5 to 10
Uncomplicated skin and skin-structure infections
250 or 500 mg every 12 hours
10
Uncomplicated urinary tract infections
250 mg every 12 hours
7 to 10
Uncomplicated gonorrhea
1,000 mg
single dose
Early Lyme disease
500 mg every 12 hours
20
Pediatric Patients younger than 13 years (who can swallow tablets whole)b
Acute bacterial otitis media
250 mg every 12 hours
10
Acute bacterial maxillary sinusitis
250 mg every 12 hours
10
2.5 Dosage in Patients with Impaired Renal FunctionA dosage interval adjustment is required for patients whose creatinine clearance is <30 mL/min, as listed in Table 4 below, because cefuroxime is eliminated primarily by the kidney [see CLINICAL PHARMACOLOGY (12.3)].
Table 4. Dosing in Adults with Renal Impairment Creatinine Clearance (mL/min)
Recommended Dosage
≥30
No dosage adjustment
10 to ˂30
Standard individual dose given every 24 hours
˂10 (without hemodialysis)
Standard individual dose given every 48 hours
Hemodialysis
A single additional standard dose should be given at the end of each dialysis
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