Oseltamivir 6 mg/mL oral suspension

Concentration

6 mg/mL

Vehicles named

Ora-Sweet, Simple syrup (Syrup NF), Cherry syrup

Container

glass bottle

The label's instructions

Preparation of Oral Suspension from 75 mg TAMIFLU Capsules The following directions are provided for use only during emergency situations and when FDA-approved, commercially manufactured TAMIFLU for oral suspension is not available from wholesalers or the manufacturer. The following emergency preparation instructions will provide one patient with enough TAMIFLU for a 5-day course of treatment of influenza or a 10-day course of prophylaxis of influenza: Step #1 : Determine the dosage of TAMIFLU for the patient [see Dosage and Administration (2.2 , 2.3 , and 2.4) ] then determine the total volume of oral suspension needed to be prepared (see Table 3 ). Table 3 Emergency Preparation: Volume of Prepared Oral Suspension (6 mg per mL) Based Upon TAMIFLU Dose TAMIFLU Dose If the TAMIFLU dose is between the doses listed, use the greater listed dose to determine the total volume of prepared oral suspension. Total Volume to Prepare per Patient 15 mg or less 37.5 mL 30 mg 75 mL 45 mg 100 mL 60 mg 125 mL 75 mg 150 mL Step #2 : Preparation must be performed with only one of the following vehicles (other vehicles have not been studied): Cherry Syrup (Humco ® ), Ora-Sweet ® SF (sugar-free) (Paddock Laboratories), or simple syrup. Determine the number of capsules and the amount of water and vehicle needed to prepare the total volume (see Table 3 ) of prepared oral suspension (6 mg per mL) for a complete treatment or prophylaxis course (see Table 4 ). Table 4 Emergency Preparation: Number of TAMIFLU 75 mg Capsules and Amount of Water and Vehicle Needed to Prepare the Total Volume of a Prepared Oral Suspension (6 mg per mL) Total Volume of Prepared Oral Suspension 37.5 mL 75 mL 100 mL 125 mL 150 mL Number of TAMIFLU 75 mg Capsules (Total Strength) Includes overage to ensure all doses can be delivered 3 (225 mg) 6 (450 mg) 8 (600 mg) 10 (750 mg) 12 (900 mg) Amount of Water 2.5 mL 5 mL 7 mL 8 mL 10 mL Volume of Vehicle Cherry Syrup (Humco ® ) OR Ora-Sweet ® SF (Paddock Laboratories) OR simple syrup 34.5 mL 69 mL 91 mL 115 mL 137 mL Step #3 : Follow the instructions below for preparing the 75 mg TAMIFLU capsules to produce the oral suspension (6 mg per mL): Place the specified amount of water into a polyethyleneterephthalate (PET) or glass bottle (see Table 4 ). Constitution in other bottle types is not recommended because there is no stability data with other bottle types. Carefully separate the capsule body and cap and pour the contents of the required number of TAMIFLU 75 mg capsules into the PET or glass bottle. Gently swirl the suspension to ensure adequate wetting of the TAMIFLU powder for at least 2 minutes. Slowly add the specified amount of vehicle to the bottle. Close the bottle using a child-resistant cap and shake well for 30 seconds to completely dissolve the active drug and to ensure homogeneous distribution of the dissolved drug in the resulting suspension. The active drug, oseltamivir phosphate, readily dissolves in the specified vehicles. The suspension is caused by inert ingredients of TAMIFLU capsules which are insoluble in these vehicles. Put an ancillary label on the bottle indicating "Shake Well Before Use." Instruct the parent or caregiver that any unused suspension remaining in the bottle following completion of therapy must be discarded by either affixing an ancillary label to the bottle or adding a statement to the pharmacy label instructions. Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, drug name and any other required information to be in compliance with all State and Federal Pharmacy Regulations. Place an appropriate expiration date on the label according to storage conditions below. Include the recommended dosage on the pharmacy label as per Tables 1 and 2 [see Dosage and Administration (2.2 , 2.3 , and 2.4) ]. Store the prepared oral suspension in glass or PET bottles either: In a refrigerator [2° to 8°C (36° to 46°F)]: Stable for 5 weeks when stored in a refrigerator. At room temperature [25°C (77°F)]: Stable for 5 days when stored at room temperature.

Quoted verbatim from the Dosage and Administration section of the FDA label for Tamiflu, version 45, effective 2025-12-15. Open the label on DailyMed. 46 current labels for this drug carry these instructions.

Storage and beyond-use date

• “Store the prepared oral suspension in glass or PET bottles either: In a refrigerator [2° to 8°C (36° to 46°F)]: Stable for 5 weeks when stored in a refrigerator.”
• “At room temperature [25°C (77°F)]: Stable for 5 days when stored at room temperature.”

Only the storage conditions the source covers are listed. Use the BUD assistant for other cases. The BUD may not be later than any component's expiration date. Verify against the current official USP chapter.

Ingredient checks

No FDA compounding list or NIOSH flags for the active ingredient.

Source

FDA label (Tamiflu), Dosage and Administration.

For licensed clinicians. Use with clinical judgment.