FDA label

Valacyclovir 25 mg/mL oral suspension

Concentration
25 mg/mL
Container
amber glass medicine bottle

The label's instructions

2.3 Extemporaneous Preparation of Oral Suspension Ingredients and Preparation per USP ‑ NF VALTREX tablets 500 mg, cherry flavor, and Suspension Structured Vehicle USP-NF (SSV). Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) should be prepared in lots of 100 mL. Instructions for Preparing Suspension at Time of Dispensing • Prepare SSV according to the USP-NF. • Using a pestle and mortar, grind the required number of VALTREX 500-mg tablets until a fine powder is produced (5 VALTREX tablets for 25-mg/mL suspension; 10 VALTREX tablets for 50-mg/mL suspension). • Gradually add approximately 5-mL aliquots of SSV to the mortar and triturate the powder until a paste has been produced. Ensure that the powder has been adequately wetted. • Continue to add approximately 5-mL aliquots of SSV to the mortar, mixing thoroughly between additions, until a concentrated suspension is produced, to a minimum total quantity of 20 mL SSV and a maximum total quantity of 40 mL SSV for both the 25-mg/mL and 50-mg/mL suspensions. • Transfer the mixture to a suitable 100-mL measuring flask. • Transfer the cherry flavor* to the mortar and dissolve in approximately 5 mL of SSV. Once dissolved, add to the measuring flask. • Rinse the mortar at least 3 times with approximately 5-mL aliquots of SSV, transferring the rinsing to the measuring flask between additions. • Make the suspension to volume (100 mL) with SSV and shake thoroughly to mix. • Transfer the suspension to an amber glass medicine bottle with a child-resistant closure. • The prepared suspension should be labeled with the following information “Shake well before using. Store suspension between 2°C to 8°C (36°F to 46°F) in a refrigerator. Discard after 28 days.” *The amount of cherry flavor added is as instructed by the suppliers of the cherry flavor.

Quoted verbatim from the Dosage and Administration section of the FDA label for VALTREX, version 32, effective 2025-11-12. Open the label on DailyMed. 85 current labels for this drug carry these instructions.

Storage and beyond-use date

StorageBUDBasis
Refrigerated28 daysStorage and duration as the FDA label states them.
  • “Store suspension between 2°C to 8°C (36°F to 46°F) in a refrigerator. Discard after 28 days.” *The amount of cherry flavor added is as instructed by the suppliers of the cherry flavor.”

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 (VALTREX), Dosage and Administration.

For licensed clinicians. Use with clinical judgment.