Physicians EZ Use B-12 Compliance
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Physicians EZ Use B-12 Compliance
- Generic name
- PHYSICIANS EZ USE B-12 COMPLIANCE
- Manufacturer
- Asclemed USA, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 168f94ea-2faf-4aeb-88a5-8753ad60a1c4
- SPL ID
- 23b3fc52-8b5a-eb5c-e063-6294a90a9754
- Version
- 6
- Effective date
- 2024-10-05
- Source export date
- 2026-09-28
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:44:43
| Harmonized routes |
|---|
| INTRAMUSCULAR, SUBCUTANEOUS, TOPICAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| brand name | Physicians EZ Use B-12 Compliance | openfda.brand_name | |
| generic name | PHYSICIANS EZ USE B-12 COMPLIANCE | openfda.generic_name | |
| manufacturer name | Asclemed USA, Inc. | openfda.manufacturer_name | |
| ndc | package | 76420-527-01 | openfda.package_ndc |
| ndc | package | 63323-044-00 | openfda.package_ndc |
| ndc | product | 76420-527 | openfda.product_ndc |
| ndc11 | package | 63323004400 | derived:openfda.package_ndc |
| ndc11 | package | 76420052701 | derived:openfda.package_ndc |
| rxcui | 309594 | openfda.rxcui | |
| rxcui | 797544 | openfda.rxcui | |
| spl id | 23b3fc52-8b5a-eb5c-e063-6294a90a9754 | id | |
| spl set id | 168f94ea-2faf-4aeb-88a5-8753ad60a1c4 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings For external use only Flammable - keep away from fire or flame Do not use with electrocautery procedures When using this product do not get into eyes apply over large areas of the body in case of deep or puncture wounds, animal bites or serious burns consult a doctor Stop use and ask a doctor if condition persists or gets worse or lasts for more than 72 hours do not use longer than 1 week unless directed by a doctor Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
warnings
WARNINGS WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Patients with early Leber’s disease (hereditary optic nerve atrophy) who were treated with cyanocobalamin suffered severe and swift optic atrophy. Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely. Anaphylactic shock and death have been reported after parenteral Vitamin B 12 administration. An intradermal test dose is recommended before cyanocobalamin injection is administered to patients suspected of being sensitive to this drug. This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal ‘‘Gasping Syndrome’’ in premature infants.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Generalized Anaphylactic shock and death have been reported with administration of parenteral Vitamin B 12 (see WARNINGS ). Cardiovascular Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis. Hematological Polycythemia vera. Gastrointestinal Mild transient diarrhea. Dermatological Itching; transitory exanthema. Miscellaneous Feeling of swelling of entire body.
adverse reactions
Generalized Anaphylactic shock and death have been reported with administration of parenteral Vitamin B 12 (see WARNINGS ).
adverse reactions
Cardiovascular Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis.
adverse reactions
Hematological Polycythemia vera.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.