FDA.reportPublic FDA data

PHUEL

Manufacturer
Relion Manufacturing | Avadim Technologies Inc.
Effective date
2021-04-26
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:14:33

Label at a glance#

ProductPHUEL
Active ingredientMAGNESIUM SULFATE HEPTAHYDRATE
Label structure2 sections

Label contents#

Full prescribing information#

0010 ifu

INSTRUCTIONS FOR USE SECTION

010 ifu010 ifu

0010 Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0010 bottle label0010 bottle label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71064-0010-32023-01-30C16284748780-1f386c649-e64f-0266-e053-dadaa90a7c1aPhuel Foam
71064-0010-72023-01-30C16284748780-1f386c649-e64f-0266-e053-dadaa90a7c1aPhuel Foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71064-0010-3PHUEL101 mL in 1 BOTTLESOLUTION1012
71064-0010-7PHUEL210 mL in 1 BOTTLESOLUTION2102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71064-0010PHUEL (MAGNESIUM SULFATE HEPTAHYDRATE) SOLUTION [RELION MANUFACTURING]2Legacy NDC, 2 package rows20210427_c0e86377-77f5-49a4-e053-2995a90a3b5b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71064-001071064-0010-7, 71064-0010-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
MAGNESIUM SULFATE HEPTAHYDRATESK47B8698TACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c0eaec17-01f1-3197-e053-2a95a90aa666c0e86377-77f5-49a4-e053-2995a90a3b5b2021-04-26Exact identifier
spl id: c0eaec17-01f1-3197-e053-2a95a90aa666
spl set id: c0e86377-77f5-49a4-e053-2995a90a3b5b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.