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FDA Labeling Changes

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History

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Sources

X Manufacturers

Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Unifirst First Aid Corporation

■ do not use more than directed
■ the smallest effective dose should be used
■ do not take longer than 10 days, unless directed by a doctor (see Warnings)
Adults and children:(12 years and older)
Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used.
Do not exceed 6 tablets in 24 hours, unless directed by a doctor.
Children under 12 years:
Do not give to children under 12 years of age.

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Ax Pharmaceutical Corp

X | Proficient Rx Lp

Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets

Do not attempt to push ondansetron orally disintegrating tablets through the foil backing. With dry hands, remove the tablet from the bottle or PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.

Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy

The recommended adult oral dosage of ondansetron orally disintegrating tablets is 24 mg given as three 8 mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.

Pediatric Use

There is no experience with the use of a 24 mg dosage in pediatric patients.

Geriatric Use

The dosage recommendation is the same as for the general population.

Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy

The recommended adult oral dosage is one 8 mg ondansetron orally disintegrating tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ondansetron orally disintegrating tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.

Pediatric Use

For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ondansetron orally disintegrating tablet given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ondansetron orally disintegrating tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.

Geriatric Use

The dosage is the same as for the general population.

Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen

The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet given 3 times a day.

For total body irradiation, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

For single high-dose fraction radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

For daily fractionated radiotherapy to the abdomen, one 8 mg ondansetron orally disintegrating tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

Pediatric Use

There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of radiation-induced nausea and vomiting in pediatric patients.

Geriatric Use

The dosage recommendation is the same as for the general population.

Postoperative Nausea and Vomiting

The recommended dosage is 16 mg given as two 8 mg ondansetron orally disintegrating tablets 1 hour before induction of anesthesia.

Pediatric Use

There is no experience with the use of ondansetron orally disintegrating tablets in the prevention of postoperative nausea and vomiting in pediatric patients.

Geriatric Use

The dosage is the same as for the general population.

Dosage Adjustment for Patients With Impaired Renal Function

The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.

Dosage Adjustment for Patients With Impaired Hepatic Function

In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Woonsocket Prescription Center,incorporated

do not take more than directed (see overdose warning) adults and children 12 years and over 2 tablets every 4 to 6 hours; do not take more than 12 tablets in 24 hours children 6 to under 12 years of age 1 tablet every 4 to 6 hours; do not take more than 5 tablets in 24 hours children under 6 years of age do not use this product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Animal Health International, Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | H E B

• if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the lozenge on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:
Weeks 1 to 6
Weeks 7 to 9
Weeks 10 to 12
1 lozenge every 1 to 2 hours
1 lozenge every 2 to 4 hours
1 lozenge every 4 to 8 hours
• nicotine lozenge is a medicine and must be used a certain way to get the best results • place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge. • you may feel a warm or tingling sensation • occasionally move the lozenge from one side of your mouth to the other until completely dissolved • do not eat or drink 15 minutes before using or while the lozenge is in your mouth • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. • it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

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Ax Pharmaceutical Corp

X | American Amenities, Inc.

Directions
Apply to Underarm Only

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Ax Pharmaceutical Corp

X | Ax Pharmaceutical Corp

There is currently no dosage information available for this product. We apologize for any inconvenience.

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