PNV Prenatal Vitamin

Manufacturer: Sancilio & Company Inc
Effective date: 2012-12-14
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:16:25

Label at a glance#

ProductPNV Prenatal Vitamin Plus Vitamin A

Active ingredient.Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, Vitamin A Acetate

Label structure9 sections

Boxed warning

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Dosage and administration

One tablet daily with a meal, or as directed by a physician.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

PNV tablets are formulated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period, for both lactating and non-lactating mothers, and is useful for improving nutritional status prior to conception.

DESCRIPTION SECTION

Each PNV tablet contains:

VITAMINS:
Vitamin A (as acetate)	2500 IU
Vitamin C (as Ascorbic Acid)	60 mg
Vitamin D3 (as Cholecalciferol)	400 IU
Vitamin E (as Tocopheryl acetate)	15 IU
Vitamin B1 (as Thiamine Mononitrate)	1.05 mg
Vitamin B2 (as Riboflavin, USP)	1.2 mg
Niacin (as Niacinamide)	13.5 mg
Vitamin B6 (as Pyridoxine HCL)	1.05 mg
Folic Acid	1 mg
Vitamin B12 (as Cyanocobalamin)	4.5 mcg
MINERAL:
Iron (as ferrous fumarate)	27 mg
Calcium (as Dibasic Calcium Phosphate)	50 mg

OTHER INGREDIENTS

SPL UNCLASSIFIED SECTION

Microcrystalline Cellulose, Croscarmellose Sodium, Citric Acid, Talc and Magnesium Stearate.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

One tablet daily with a meal, or as directed by a physician.

CAUTION

PRECAUTIONS SECTION

Folic acid may partially correct the hematological damage due to vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses.

WARNING

BOXED WARNING SECTION

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

In some cases, allergic hypersensitivity has been reported following administration of folic acid. Mild gastrointestinal disturbances may occur with products containing ferrous fumarate (iron), but usually subside with continuation of therapy.

HOW SUPPLIED SECTION

STORAGE AND HANDLING SECTION

STORE AT CONTROLLED ROOM TEMPERATURE 15°-30°C (59°-86°F). PROTECT FROM EXCESS HEAT AND MOISTURE. Dispense in a tight, light-resistant container with child-resistant closure.

SPL UNCLASSIFIED SECTION

This medical food product is formulated to be administered orally, under the supervision of a physician and is intended for the management of a dietary deficiency of folic acid and iron for which a distinctive nutritional requirement, based on recognized scientific principles, has been established by medical evaluation. The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health insurance and state level reimbursement programs and is not intended to denote registration or approval from the FDA.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING.

Manufactured by: Sancilio & Company, Inc.,
Riviera Beach, FL 33404
(800) SCI-8711

REV: 12/07/12

PRINCIPAL DISPLAY PANEL - 400 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44946-1046-4
Rx only

PNV Prenatal Health
PNV
Prenatal Vitamins

FOLIC ACID + IRON
MULTIVITAMIN
PLUS VITAMIN A
Tablets

Provides vitamin and
mineral supplementation
throughout pregnancy
and postnatal period

Sugar & Gluten Free

SCI
Sancilio & Company, Inc
Developing good science into great medicine

400
TABLETS

PRINCIPAL DISPLAY PANEL - 400 Tablet Bottle Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ASCORBIC ACID Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
CHOLECALCIFEROL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
CYANOCOBALAMIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
PYRIDOXINE Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20170310
VITAMIN A Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cf050ccd-1144-f76a-e00d-e5698d8597d4	Product name	6	20250625
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8	Product name	2	20240805
91c62db0-0295-c81c-d10a-0856c259edd6	Product name	2	20200428
d32bc2b8-0bb7-2216-87aa-24639646e202	Product name	3	20190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
d206bb34-ea65-399d-70d9-834f22dc2c18	Product name	3	20170724
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
44946-1046-0	2019-11-27	C162847	48780-1	9855d018-d997-cd31-e053-dbdaa90ab51a	PNV Prenatal Health™ - Prenatal Vitamins
44946-1046-2	2019-11-27	C162847	48780-1	9855d018-d997-cd31-e053-dbdaa90ab51a	PNV Prenatal Health™ - Prenatal Vitamins
44946-1046-4	2019-11-27	C162847	48780-1	9855d018-d997-cd31-e053-dbdaa90ab51a	PNV Prenatal Health™ - Prenatal Vitamins

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
44946-1046-0	PNV Prenatal VitaminPlus Vitamin A	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
44946-1046-2	PNV Prenatal VitaminPlus Vitamin A	90 in 1 BOTTLE, PLASTIC	TABLET	90	1
44946-1046-4	PNV Prenatal VitaminPlus Vitamin A	400 in 1 BOTTLE, PLASTIC	TABLET	400	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44946-1046	PNV PRENATAL VITAMIN PLUS VITAMIN A (.ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CHOLECALCIFEROL, CYANOCOBALAMIN, FOLIC ACID, FERROUS FUMARATE, CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE MONONITRATE, AND VITAMIN A ACETATE) TABLET [SANCILIO & COMPANY INC]	1	Legacy NDC, 3 package rows	20130112_97b99e3f-0bc6-46a5-956d-9141d22f3d87.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44946-1046-0	EA - Each	44946-1046	f0410b59-0658-4b77-a036-1bb3fb462abb	1	2013-03-03
44946-1046-2	EA - Each	44946-1046	2a2a19a4-254d-4d21-9d7c-6e62480a674d	1	2013-03-03
44946-1046-4	EA - Each	44946-1046	66d4c1a8-3e13-4baa-b510-91de6220bce0	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
.Alpha.-Tocopherol Acetate, DL-	ACTIVE INGREDIENT	WR1WPI7EW8	1
Ascorbic Acid	ACTIVE INGREDIENT	PQ6CK8PD0R	1
Calcium Phosphate, Dibasic, Anhydrous	ACTIVE INGREDIENT	L11K75P92J	1
Cholecalciferol	ACTIVE INGREDIENT	1C6V77QF41	1
Cyanocobalamin	ACTIVE INGREDIENT	P6YC3EG204	1
Ferrous fumarate	ACTIVE INGREDIENT	R5L488RY0Q	1
Folic Acid	ACTIVE INGREDIENT	935E97BOY8	1
Niacinamide	ACTIVE INGREDIENT	25X51I8RD4	1
Pyridoxine Hydrochloride	ACTIVE INGREDIENT	68Y4CF58BV	1
Riboflavin	ACTIVE INGREDIENT	TLM2976OFR	1
Thiamine Mononitrate	ACTIVE INGREDIENT	8K0I04919X	1
Vitamin A Acetate	ACTIVE INGREDIENT	3LE3D9D6OY	1
.Alpha.-Tocopherol, DL-	ACTIVE MOIETY	7QWA1RIO01	1
Ascorbic Acid	ACTIVE MOIETY	PQ6CK8PD0R	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ACTIVE MOIETY	L11K75P92J	1
Cholecalciferol	ACTIVE MOIETY	1C6V77QF41	1
Cyanocobalamin	ACTIVE MOIETY	P6YC3EG204	1
Ferrous cation	ACTIVE MOIETY	GW89581OWR	1
Folic Acid	ACTIVE MOIETY	935E97BOY8	1
Niacinamide	ACTIVE MOIETY	25X51I8RD4	1
Pyridoxine	ACTIVE MOIETY	KV2JZ1BI6Z	1
Riboflavin	ACTIVE MOIETY	TLM2976OFR	1
Thiamine Ion	ACTIVE MOIETY	4ABT0J945J	1
VITAMIN A	ACTIVE MOIETY	81G40H8B0T	1
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	1
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	1
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	1

Products#

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

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

PNV Prenatal Vitamin Plus Vitamin A
.Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, and Vitamin A Acetate
.Alpha.-Tocopherol Acetate, DL-
.Alpha.-Tocopherol, DL-
Ascorbic Acid
Cholecalciferol
Cyanocobalamin
Folic Acid
Ferrous fumarate
Ferrous cation
Calcium Phosphate, Dibasic, Anhydrous
Niacinamide
Pyridoxine Hydrochloride
Pyridoxine
Riboflavin
Thiamine Mononitrate
Thiamine Ion
Thiamine
Vitamin A Acetate
VITAMIN A
Cellulose, Microcrystalline
Croscarmellose sodium
Anhydrous Citric Acid
Talc
Magnesium stearate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
44946-1046	44946-1046-0, 44946-1046-2, 44946-1046-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
.Alpha.-Tocopherol Acetate, DL-	WR1WPI7EW8	ACTIM
Ascorbic Acid	PQ6CK8PD0R	ACTIB
Cholecalciferol	1C6V77QF41	ACTIB
Cyanocobalamin	P6YC3EG204	ACTIB
Folic Acid	935E97BOY8	ACTIB
Ferrous fumarate	R5L488RY0Q	ACTIM
Calcium Phosphate, Dibasic, Anhydrous	L11K75P92J	ACTIB
Niacinamide	25X51I8RD4	ACTIB
Pyridoxine Hydrochloride	68Y4CF58BV	ACTIB
Riboflavin	TLM2976OFR	ACTIB
Thiamine Mononitrate	8K0I04919X	ACTIR
Vitamin A Acetate	3LE3D9D6OY	ACTIM
Cellulose, Microcrystalline	OP1R32D61U	IACT
Croscarmellose sodium	M28OL1HH48	IACT
Anhydrous Citric Acid	XF417D3PSL	IACT
Talc	7SEV7J4R1U	IACT
Magnesium stearate	70097M6I30	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 185 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Talc	TALC	7SEV7J4R1U	TABLET / SUBLINGUAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Magnesium stearate	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE, LIQUID FILLED / ORAL		360 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / ORAL		84 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / ORAL		197 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, CHEWABLE / ORAL		202 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Magnesium stearate	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / BUCCAL		18 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / SUBLINGUAL		36 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EFFERVESCENT / ORAL		840 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		414 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Magnesium stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL		330 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		81 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL	ADJ PH		Exact identifier — unii candidate 61 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, EXTENDED RELEASE / ORAL		1246 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE / ORAL		257 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	LOTION / TOPICAL		211 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	LIQUID / INTRAVENOUS		18 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	PELLET / ORAL		162 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	AEROSOL, FOAM / TOPICAL		6 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	LOZENGE / TRANSMUCOSAL		44 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	OIL / TOPICAL		2 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	GRANULE, FOR SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / RECTAL		904 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Magnesium stearate	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, CHEWABLE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		18 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Magnesium stearate	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EXTENDED RELEASE / ORAL		312 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FOR SUSPENSION / ORAL		1875 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SOLUTION / ORAL		123 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		35 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Magnesium stearate	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium stearate	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SUSPENSION / ORAL		570 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE PELLETS / ORAL		127 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	PELLET / ORAL		69 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	GRANULE, FOR SUSPENSION / ORAL		296 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Magnesium stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium stearate	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	GEL / TOPICAL		3 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Anhydrous Citric Acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION, EXTENDED RELEASE / ORAL		62 mg	Exact identifier — unii candidate 61 equally ranked IID candidates

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
f3af7e93-287a-4e40-9934-daf64e15efde			97b99e3f-0bc6-46a5-956d-9141d22f3d87	2012-12-14	Boxed warning, Adverse reactions	Exact identifier spl id: f3af7e93-287a-4e40-9934-daf64e15efde spl set id: 97b99e3f-0bc6-46a5-956d-9141d22f3d87

Reported adverse events (FAERS/openFDA)#

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