FDA.reportPublic FDA data

ULTRA PCOS CITRUS

Manufacturer
CROWN GENERAL AGENCY INC
Effective date
2021-10-22
Label type
Dietary Supplement
Version
2
Source
full-release
Hydrated at
2026-06-01 02:50:11

Label at a glance#

ProductULTRA PCOS CITRUS
Active ingredientACETYLCYSTEINE, GAMOLENIC ACID, GYMNEMA SYLVESTRE LEAF, INOSITOL, CHINESE CINNAMON, ARGININE HYDROCHLORIDE, LEVOCARNITINE TARTRATE, UBIDECARENONE, THIOCTIC ACID, ALTHAEA OFFICINALIS ROOT, GLUTATHIONE, CHIRO-INOSITOL, (+)-, LAGERSTROEMIA SPECIOSA WHOLE
Label structure4 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY

STATEMENT OF IDENTITY SECTION

Dietary Supplement

Suggested Use

DOSAGE & ADMINISTRATION SECTION

Take two (2) capsules daily, after meal(s), or as directed by your healthcare provider. Do not exceed two (2) capsules daily.

Precaution

SAFE HANDLING WARNING SECTION

If reaction(s) occur, consult your physician. Consult your doctor before starting any dietary supplement regime. This product is a dietary supplement, not a prescription drug. Keep out of the reach of children. In case of accidental overdose, call a hospital or poison control center immediately. Do not use if safety seal is damaged or missing. Do not expose to excessive heat or moisture. Store at room temperature in a cool dry place. Keep out of sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ACETYLCYSTEINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
LEVOCARNITINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
13c3e0af-2da2-8aec-9e17-1afd680d80c2Product name820221116
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
f46c867f-cde5-4f14-a7c1-18ae3a6efd1cProduct name120160303
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73489-006-01ULTRA PCOS CITRUS30 in 1 BOTTLE, PLASTICCAPSULE302
73489-006-02ULTRA PCOS CITRUS60 in 1 BOTTLE, PLASTICCAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73489-006ULTRA PCOS CITRUS (ACETYLCYSTEINE, GAMOLENIC ACID, GYMNEMA SYLVESTRE LEAF, INOSITOL, CHINESE CINNAMON, ARGININE HYDROCHLORIDE, LEVOCARNITINE TARTRATE, UBIDECARENONE, THIOCTIC ACID, ALTHAEA OFFICINALIS ROOT, GLUTATHIONE, CHIRO-INOSITOL, LAGERSTROEMIA SPECIOSA WHOLE) CAPSULE [CROWN GENERAL AGENCY INC]22 package rows20211023_ea4c673b-e4f2-4fdc-bb1e-07ac0df0b436.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73489-006-01EA - Each73489-006e0d95c94-169c-46ea-af65-37d6cee112f012021-01-08
73489-006-02EA - Each73489-0062a3f142c-b51b-404c-9f1d-a28497f3252312021-01-08

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73489-00673489-006-01, 73489-006-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETYLCYSTEINEWYQ7N0BPYCACTIB
GAMOLENIC ACID78YC2MAX4OACTIB
GYMNEMA SYLVESTRE LEAF2ZK6ZS8392ACTIB
INOSITOL4L6452S749ACTIB
CHINESE CINNAMONWS4CQ062KMACTIB
ARGININE HYDROCHLORIDEF7LTH1E20YACTIB
LEVOCARNITINE TARTRATE4D8F2Q45LQACTIB
UBIDECARENONEEJ27X76M46ACTIB
THIOCTIC ACID73Y7P0K73YACTIB
ALTHAEA OFFICINALIS ROOTTRW2FUF47HACTIB
GLUTATHIONEGAN16C9B8OACTIB
CHIRO-INOSITOL, (+)-6R79WV4R10ACTIB
LAGERSTROEMIA SPECIOSA WHOLEUOV610JOOFACTIB
POWDERED CELLULOSESMD1X3XO9MIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetylcysteineACETYLCYSTEINEHospira, Inc.5558a5f5-e821-473b-7d8a-5d33d09f05862026-05-22Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEGlenmark Pharmaceuticals Inc., USAf811ddfc-d7c1-4637-ae81-80c38a77cb802026-05-06Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINESomerset Therapeutics, LLCd50c8ab6-26f8-4669-89d1-c4d26698159a2026-04-11Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINECardinal Health 107, LLCc90fca12-12fb-4cf6-bd6f-83bc0d95df812026-04-07Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEEugia US LLC5ae53725-1abb-4122-9c85-f26c2c31566c2025-12-02Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINESagent Pharmaceuticalsc206c659-16ea-444a-8c60-8a3343400ada2025-10-26Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEONESOURCE SPECIALTY PHARMA LIMITED3b0310d2-4e70-4b94-8d69-cb5999a32b542025-09-12Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEHikma Pharmaceuticals USA Inc.277963a0-8ab2-4305-a688-28e47e87c5842025-09-09Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINECameron Pharmaceuticals8165ad85-98e7-438f-9567-5cfda88d0ebf2025-08-26Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
acetylcysteineACETYLCYSTEINEPadagis US LLC9d305722-e74f-4f48-8d2c-0daa991447492025-07-31Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
ACETADOTEACETYLCYSTEINECumberland Pharmaceuticals Inc.472f158a-5ab9-4308-8e49-1116e6ea3d392025-04-30Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEAmerican Regent, Inc.f56b4087-db48-4fd7-84ec-9c927962b8052024-12-17Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLC75b48fab-cef6-465c-a1e0-d085b3988bc42024-08-15Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINESomerset Therapeutics, LLCb8d3ed96-d7ee-43f4-986c-a7d04808711a2024-06-13Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEXellia Pharmaceuticals USA LLC3e2e187e-2445-43b1-b66c-b828e2adf0222023-05-31Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLC8cca4e4c-85a2-d575-e053-2995a90a65992022-10-31Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLCd990ef51-ced2-4359-b99b-092334d2dc9b2022-10-31Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINEFresenius Kabi USA, LLC8d81039e-20ef-5144-e053-2a95a90a89fd2022-10-31Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
AcetylcysteineACETYLCYSTEINESagent Pharmaceuticals2324d60b-4f49-4759-a46e-a06bfce7e8aa2022-04-05Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE
ACETYLCYSTEINEACETYLCYSTEINEIndoco Remedies Limited6588c28d-0515-4cdf-99d3-c4ad3fd0976c2022-03-01Warnings, Adverse reactionsName fallback
generic name: ACETYLCYSTEINE

Reported adverse events (FAERS/openFDA)#

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