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This is completely normal for low-dose B12 additions

What's inside: 1 Hospira (Pfizer) Bacteriostatic Water for Injection, USP sealed 30 mL multi-dose vial

Dosage & Administration Take as directed by a healthcare professional Usually one softgel daily after meals Swallow whole with water Do not exceed recommended dosage Side Effects Mild gastric discomfort Nausea (rare) Headache (rare) Allergic reaction in sensitive individuals Precautions Consult doctor before use in pregnancy or lactation Use cautiously in patients with bleeding disorders Avoid if allergic to any ingredient Not intended as a substitute for a balanced diet Storage Store in a cool, dry place away from direct sunlight

For example, you may be able to rely on foreign clinical data for Class A devices, but you may need to conduct additional clinical trials for Class C or Class D devices