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CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: AND 077415Orig1s017 Name: Hydrochloride ExtendedRelease Tablets USP (XL) 150 mg and 300 mg Sponsor: Imp ax Laboratories,
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How to fill out hydrochloride extended-release tablets usp

How to fill out hydrochloride extended-release tablets USP:
01
Wash your hands thoroughly before handling the tablets to maintain cleanliness.
02
Remove the hydrochloride extended-release tablets USP from the packaging, ensuring not to damage them.
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Read the instructions provided with the tablets carefully to understand the correct dosage and administration.
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Place the tablets on a clean, flat surface.
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If required, use a pill cutter or splitter to divide the tablets into the recommended dosage, as specified by your healthcare professional.
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Take a glass of water and swallow the tablets whole. Do not crush or chew them unless advised otherwise by your doctor or pharmacist.
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Ensure to drink enough water to aid in the swallowing process and to ensure proper absorption of the medication.
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Store the remaining tablets in the original packaging, away from direct sunlight, moisture, and heat, following the storage guidelines provided.
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Keep the medication out of reach of children and pets.
Who needs hydrochloride extended-release tablets USP:
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Patients diagnosed with a medical condition or disease for which hydrochloride extended-release tablets USP are indicated by their healthcare provider.
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Individuals who require long-lasting or sustained-release effect of the medication to maintain a consistent level of the active ingredient in their body.
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Patients who have difficulties swallowing regular tablets or need a specific formulation that can be taken less frequently.
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People who have previously shown a positive response to the medication or have been prescribed hydrochloride extended-release tablets USP before.
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Those who have undergone proper medical evaluation and have received a valid prescription from a licensed healthcare professional.
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What is hydrochloride extended-release tablets usp?
Hydrochloride extended-release tablets USP are a type of medication that releases the active ingredient slowly into the body over an extended period of time.
Who is required to file hydrochloride extended-release tablets usp?
The manufacturer or distributor of the hydrochloride extended-release tablets USP is required to file the necessary documentation.
How to fill out hydrochloride extended-release tablets usp?
To fill out the necessary forms for hydrochloride extended-release tablets USP, the manufacturer or distributor must provide detailed information about the medication.
What is the purpose of hydrochloride extended-release tablets usp?
The purpose of hydrochloride extended-release tablets USP is to provide a controlled release of the medication into the body, allowing for longer-lasting effects.
What information must be reported on hydrochloride extended-release tablets usp?
Information such as the active ingredient, dosage strength, manufacturing process, and potential side effects must be reported on hydrochloride extended-release tablets USP.
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