FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (2,600 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
• more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this productSore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
ask a health professional before use.
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
temporarily relieves common cold/flu symptoms:
• nasal congestion • sinus congestion and pressure • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • cough due to minor throat and bronchial irritation • cough to help you sleep • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the noseHistory
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Atorak Chamomile Atocare Pure Manufacturers
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Dasan E&t Co., Ltd.
Atorak Chamomile Atocare Pure | Cardinal Health
Omeprazole delayed-release capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with omeprazole.
Patients should be informed that the omeprazole delayed-release capsule should be swallowed whole.
For patients unable to swallow an intact capsule, alternative administration options are available [See Dosage and Administration (2.8)].
2.1 Short-Term Treatment of Active Duodenal UlcerThe recommended adult oral dose of omeprazole delayed-release capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
2.2 H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer RecurrenceTriple Therapy (omeprazole/clarithromycin/amoxicillin)
The recommended adult oral regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.Dual Therapy (omeprazole/clarithromycin)
2.3 Gastric Ulcer
The recommended adult oral regimen is omeprazole delayed-release capsules 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief.The recommended adult oral dose is 40 mg once daily for 4 to 8 weeks.
2.4 Gastroesophageal Reflux Disease (GERD)The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks.
2.5 Maintenance of Healing of Erosive EsophagitisThe recommended adult oral dose is 20 mg daily [See Clinical Studies (14.4)].
2.6 Pathological Hypersecretory ConditionsThe dosage of omeprazole delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with omeprazole delayed-release capsules for more than 5 years.
2.7 Pediatric PatientsFor the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 2 to 16 years of age is as follows:
Patient Weight Omeprazole Daily Dose10 < 20 kg
10 mg
≥ 20 kg
20 mg
On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.
Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [See Dosage and Administration (2.8)].
2.8 Alternative Administration OptionsOmeprazole is available as a delayed-release capsule.
For patients who have difficulty swallowing capsules, the contents of an omeprazole delayed-release capsule can be added to applesauce.
One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.
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