Flavoxate Hydrochloride Tablets 100 mg, Film-Coated Rx only

Manufacturer: PuraCap Laboratories LLC dba Blu Pharmaceuticals | Epic Pharma, LLC
Effective date: 2025-12-11
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 21:49:53

Label at a glance#

ProductFlavoxate Hydrochloride

Active ingredientFLAVOXATE HYDROCHLORIDE

Label structure11 sections

Indications and uses

Flavoxate hydrochloride tablets are indicated for symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis. Flavoxate hydrochloride tablets are not indicated for definitive treatment, but are compatible with drugs used for the treatment of urinary tract infections.

Dosage and administration

One or two 100 mg tablets 3 or 4 times a day. With improvement of symptoms, the dose may be reduced. This drug cannot be recommended for infants and children under 12 years of age because safety and efficacy have not been demonstrated in this age group.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Flavoxate hydrochloride tablets contain flavoxate hydrochloride, a synthetic urinary tract spasmolytic.

Chemically, flavoxate hydrochloride is 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4 H-1-benzopyran-8-carboxylate hydrochloride. The empirical formula of flavoxate hydrochloride is C ₂₄H ₂₅NO ₄•HCl. The molecular weight is 427.94. The structural formula appears below.

Each tablet for oral administration contains 100 mg flavoxate hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Flavoxate hydrochloride counteracts smooth muscle spasm of the urinary tract and exerts its effect directly on the muscle.

In a single study of 11 normal male subjects, the time to onset of action was 55 minutes. The peak effect was observed at 112 minutes. 57% of the flavoxate hydrochloride was excreted in the urine within 24 hours.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Flavoxate hydrochloride is contraindicated in patients who have any of the following obstructive conditions: pyloric or duodenal obstruction, obstructive intestinal lesions or ileus, achalasia, gastrointestinal hemorrhage and obstructive uropathies of the lower urinary tract.

WARNINGS

WARNINGS SECTION

Flavoxate hydrochloride should be given cautiously in patients with suspected glaucoma.

PRECAUTIONS

PRECAUTIONS SECTION

Information for Patients

INFORMATION FOR PATIENTS SECTION

Patients should be informed that if drowsiness and blurred vision occur, they should not operate a motor vehicle or machinery or participate in activities where alertness is required.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of flavoxate hydrochloride have not been performed.

Pregnancy

PREGNANCY SECTION

Teratogenic Effects-Pregnancy Category B

SPL UNCLASSIFIED SECTION

Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate hydrochloride. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

NURSING MOTHERS SECTION

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when flavoxate hydrochloride is administered to a nursing woman.

Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness in children below the age of 12 years have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

Gastrointestinal: Nausea, vomiting, dry mouth.

CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness.

Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug).

Cardiovascular: Tachycardia and palpitation.

Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia.

Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.

Renal: Dysuria.

OVERDOSAGE

OVERDOSAGE SECTION

The oral LD ₅₀ for flavoxate hydrochloride in rats is 4273 mg/kg. The oral LD ₅₀ for flavoxate hydrochloride in mice is 1837 mg/kg.

It is not known whether flavoxate hydrochloride is dialyzable.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years of age

SPL UNCLASSIFIED SECTION

HOW SUPPLIED

HOW SUPPLIED SECTION

Flavoxate hydrochloride 100 mg tablets are available as white, round biconvex, film-coated tablets, debossed “Є58” on one side and plain on the other side.

They are supplied as follows:

NDC 24658-720-01 in bottles of 100

Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container.

Distributed by:

PuraCap Laboratories, LLC

DBA Blu Pharmaceuticals

Greenvale, NY 11548

Rev. 02-2025-00

MF058REV02/25

OE2582

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 mg 100ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Flavoxate Hydrochloride Tablets, 100 mg

Rx Only

100 Film-Coated Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1095229	flavoxATE HCl 100 MG Oral Tablet	PSN	6
1095229	flavoxate hydrochloride 100 MG Oral Tablet	SCD	6

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FLAVOXATE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0324658720012	GTIN-13: 0324658720012 EAN-13: 0324658720012 GTIN-12: 324658720012 UPC-A: 324658720012 GTIN storage (14 digits): 00324658720012	flavoxate-100mg-100ct.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24658-720-01	Flavoxate Hydrochloride	100 in 1 BOTTLE	TABLET	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24658-720-01	EA - Each	24658-720	a9605c80-b659-4496-96c2-93da1eddbe25	1	2017-06-15

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Flavoxate Hydrochloride
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (50 MPA.S)
POLYDEXTROSE
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
TRIACETIN
FLAVOXATE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
24658-720	24658-720-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
HYPROMELLOSE 2910 (50 MPA.S)	1IVH67816N	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
POLYETHYLENE GLYCOL 8000	Q662QK8M3B	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
FLAVOXATE HYDROCHLORIDE	9C05J6089W	ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	IACT

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076835-001	FLAVOXATE HYDROCHLORIDE	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2005-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076835-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076835-001	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2005-11-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076835-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076835-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076835-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076835-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076835-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076835-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076835-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076835-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076835-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076835-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076835-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076835-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076835-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076835-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076835-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076835-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076835-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076835-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076835-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076835-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076835-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076835-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076835-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076835-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076835-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076835-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076835-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076835-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076835-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076835-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076835-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076835-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076835-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076835-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076835-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076835-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076835-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076835-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076835-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076835-001	AB	1	`f41ea6bd6efb…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flavoxate Hydrochloride	FLAVOXATE HYDROCHLORIDE	PuraCap Laboratories LLC dba Blu Pharmaceuticals	f6a06eda-2480-4c0d-8d1e-9e3e89d3ee88	2025-12-11	Warnings, Adverse reactions	Exact identifier ndc (package): 24658-720-01 ndc (product): 24658-720 ndc11 (package): 24658072001 spl id: cdb3dd6e-969c-4f0c-888b-a3e1b7062fda spl set id: f6a06eda-2480-4c0d-8d1e-9e3e89d3ee88

Reported adverse events (FAERS/openFDA)#

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