FDA records indicate that there are no current recalls for this drug.
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Theraflu Expressmax Nighttime Severe Cold And Cough Recall
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Questions & Answers
Side Effects & Adverse Reactions
Warnings: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.
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
Indications & Usage: 1. After washing, apply facial toner on the face with gentle massage. 2. Duel Mask consists of 2 parts. Firstly remove transparent plastic from the sheet to cover onto the upper face by eyes and nose level and then remove white-pearled plastic after fixing the sheet. Repeat the same process with lower mask for mouth part. 3. Leave up to 40 minutes till dried and lifted thoroughly. You may do your daily life while waiting. 4. Gently take it off from ear area. You can see sebum and debris on the hardened sheet modeled from your face. 5. Rinse your face with lukewarm water.
[Professional's Note] Recommended to use cream around your eye & mouth area for better treatment.
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Theraflu Expressmax Nighttime Severe Cold And Cough Manufacturers
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Novartis Consumer Health, Inc.
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Novartis Consumer Health, Inc.
Theraflu Expressmax Nighttime Severe Cold And Cough | Cardinal Health
Instructions for Use/Handling Ondansetron Orally Disintegrating Tablets USP:Do not attempt to push ondansetron orally disintegrating tablets USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet USP 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 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 tablet USP or one 8-mg ondansetron orally disintegrating tablet USP 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 tablet USP or one 8-mg ondansetron orally disintegrating tablet USP 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 tablet USP or one 4-mg ondansetron orally disintegrating tablet USP 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 tablet USP or one 4-mg ondansetron orally disintegrating tablet USP 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 tablet USP or one 8-mg ondansetron orally disintegrating tablet USP given 3 times a day.
For total body irradiation, one 8-mg ondansetron tablet USP or one 8-mg ondansetron orally disintegrating tablet USP 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 tablet USP or one 8-mg ondansetron orally disintegrating tablet USP 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 tablet USP or one 8-mg ondansetron orally disintegrating tablet USP 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 tablets USP or ondansetron orally disintegrating tablets USP in the prevention of postoperative 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 tablets USP or two 8-mg ondansetron orally disintegrating tablets USP 1 hour before induction of anesthesia.
Pediatric Use:There is no experience with the use of ondansetron tablets USP or ondansetron orally disintegrating tablets USP 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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