Prenatal Plus Vitamin and Mineral Tablet

Manufacturer: AvKARE, Inc.
Effective date: 2020-01-17
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 10
Source: legacy-cache
Hydrated at: 2026-08-01 23:45:28

Label at a glance#

ProductPRENATAL PLUS

Active ingredientVITAMIN A ACETATE, CYANOCOBALAMIN, ASCORBIC ACID, CHOLECALCIFEROL, FOLIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, .BETA.-CAROTENE, ZINC OXIDE, CALCIUM CARBONATE, FERROUS FUMARATE, PYRIDOXINE HYDROCHLORIDE, CUPRIC OXIDE

Label structure8 sections

Boxed warning

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

Storage and handling

STORE AT CONTROLLED ROOM TEMPERATURE 15 0 - 30 0 C (59 0 - 86 0 F). AVOID EXCESS HEAT.

Contacts and useful links#

PhoneLabel contact1-855-361-3993

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Prenatal Plus Vitamin and Mineral Tablet is an Tan-Yellow colored, modified oval biconvex film coated tablet debossed G12 on one side, and provides 10 vitamins and 4 minerals to supplement the diet before, during and after pregnancy.

Each Prenatal Plus tablet Contains:

Vitamin A (Acetate and Beta Carotene) .......................................4000 I.U.

Vitamin C (Ascorbic acid)……………………………………...........….120 mg

Vitamin D-3 (Cholecalciferol)……………….....................................400 I.U.

Vitamin E (dl- Alpha Tocopheryl Acetate)……………………...............22 mg

Thiamine (Vitamin B-1 from Thiamine Mononitrate………............…1.84 mg

Riboflavin (Vitamin B-2)………………………………………...............…3 mg

Niacin(Niacinamide)…………………………………………………….... 20 mg

Vitamin B-6 (Pyridoxine HCl)…………………………………................10 mg

Folic Acid……………………………………………………............……...1 mg

Vitamin B-12 (Cyanocobalamin)……………………………................12 mcg

Calcium (Calcium Carbonate)……………………………….........…....200 mg

Iron (Ferrous Fumarate)………………………………………...........…...27 mg

Zinc (Zinc Oxide)………………………………………………...........…..25 mg

Copper (Cupric Oxide)…………………………………………...........… ..2 mg

Other ingredients: croscarmellose sodium, FD&C Blue #2, FD&C Red #40, FD&C Yellow #5, FD&C Yellow #6, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, silicon, starch, stearic acid, talc,
titanium dioxide

Indication

INDICATIONS & USAGE SECTION

To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non lactating mother. It is also useful for improving nutritional status prior to conception

Dosage

DOSAGE & ADMINISTRATION SECTION

As a dietary adjunct before, during and after pregnancy, take one tablet daily with a meal, or as directed by a physician.

BOXED WARNING SECTION

Precautions

WARNINGS AND PRECAUTIONS SECTION

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

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

STORAGE AND HANDLING SECTION

STORE AT CONTROLLED ROOM TEMPERATURE 15 ⁰ - 30 ⁰C (59 ⁰ - 86 ⁰F). AVOID EXCESS HEAT.

HOW SUPPLIED SECTION

Dispense in a well closed light-resistant container, with a child resistant container.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vitamin and Mineral
Tablet

Multi-Vitamin

Rx Only 100 Tablets

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

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

Questions or comments call 1-855-361-3993

Manufactured For:
AvKARE, Inc.
Pulaski, TN 38478

Mfg.Rev. 09/12 AV Rev. 07/17 (P)

NDC 42291-686-01

Prenatal Plus

Vitamin and Mineral
Tablet

Multi-Vitamin

100 Tablets Rx Only

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

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

Manufactured For: AvKARE, Inc.
Pulaski, TN 38478

Prenatal Plus Vitamin and Mineral Tablet (100 Tablets)

Mfg. Rev. 09/12
AV Rev. 07/17 (P)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42291-686-01	2023-03-01	C162847	48780-1	d6a99b39-51f2-a426-e053-dadaa90af4c2	Prenatal Plus Vitamin and Mineral Tablet
42291-686-01	2022-01-28	C162847	48780-1	d6a99b39-51f2-a426-e053-dadaa90af4c2	Prenatal Plus Vitamin and Mineral Tablet

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-686-01	EA - Each	42291-686	72214b5c-d9d1-476a-8194-906baf7ca295	1	2013-02-13
65162-668-10	EA - Each	65162-668	4a4ff724-e95b-437f-8203-5bda0238752d	1	2012-07-24
65162-668-50	EA - Each	65162-668	3d38ed15-6585-49a5-a931-5f89421854a3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
.ALPHA.-TOCOPHEROL ACETATE, DL-	ACTIVE INGREDIENT	WR1WPI7EW8	5
.beta.-carotene	ACTIVE INGREDIENT	01YAE03M7J	5
ASCORBIC ACID	ACTIVE INGREDIENT	PQ6CK8PD0R	5
CALCIUM CARBONATE	ACTIVE INGREDIENT	H0G9379FGK	5
CHOLECALCIFEROL	ACTIVE INGREDIENT	1C6V77QF41	5
CUPRIC OXIDE	ACTIVE INGREDIENT	V1XJQ704R4	5
CYANOCOBALAMIN	ACTIVE INGREDIENT	P6YC3EG204	5
FERROUS FUMARATE	ACTIVE INGREDIENT	R5L488RY0Q	5
FOLIC ACID	ACTIVE INGREDIENT	935E97BOY8	5
NIACINAMIDE	ACTIVE INGREDIENT	25X51I8RD4	5
PYRIDOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	68Y4CF58BV	5
RIBOFLAVIN	ACTIVE INGREDIENT	TLM2976OFR	5
Thiamine Mononitrate	ACTIVE INGREDIENT	8K0I04919X	5
VITAMIN A ACETATE	ACTIVE INGREDIENT	3LE3D9D6OY	5
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	5
.alpha.-tocopherol, Dl-	ACTIVE MOIETY	7QWA1RIO01	5
.beta.-carotene	ACTIVE MOIETY	01YAE03M7J	5
ASCORBIC ACID	ACTIVE MOIETY	PQ6CK8PD0R	5
CALCIUM CATION	ACTIVE MOIETY	2M83C4R6ZB	5
CHOLECALCIFEROL	ACTIVE MOIETY	1C6V77QF41	5
Cupric Cation	ACTIVE MOIETY	8CBV67279L	5
CYANOCOBALAMIN	ACTIVE MOIETY	P6YC3EG204	5
Ferrous Cation	ACTIVE MOIETY	GW89581OWR	5
FOLIC ACID	ACTIVE MOIETY	935E97BOY8	5
Niacinamide	ACTIVE MOIETY	25X51I8RD4	5
PYRIDOXINE	ACTIVE MOIETY	KV2JZ1BI6Z	5
RIBOFLAVIN	ACTIVE MOIETY	TLM2976OFR	5
Thiamine Ion	ACTIVE MOIETY	4ABT0J945J	5
Vitamin A	ACTIVE MOIETY	81G40H8B0T	5
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	5
.alpha.-tocopherol, Dl-	INACTIVE INGREDIENT	7QWA1RIO01	5
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	5
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	5
Calcium Phosphate, Dibasic, Dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	5
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	5
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	5
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	5
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	5
SODIUM ASCORBATE	INACTIVE INGREDIENT	S033EH8359	5
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	5
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	5
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	5

Products#

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

DailyMed product names page 1 of 2 · 49 matching rows.

PRENATAL PLUS
VITAMIN A ACETATE, BETA CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE
ASCORBYL PALMITATE
BUTYLATED HYDROXYTOLUENE
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
.ALPHA.-TOCOPHEROL, DL-
FD&C RED NO. 40
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSES
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
PROPYLENE GLYCOL
SILICON DIOXIDE
SODIUM ASCORBATE
SODIUM BENZOATE
SORBIC ACID
STEARIC ACID
SUCROSE
SUNFLOWER OIL
TITANIUM DIOXIDE
TRIACETIN
VITAMIN A ACETATE
VITAMIN A
CYANOCOBALAMIN
ASCORBIC ACID
CHOLECALCIFEROL
FOLIC ACID
THIAMINE MONONITRATE
THIAMINE ION
THIAMINE
RIBOFLAVIN
NIACINAMIDE
.ALPHA.-TOCOPHEROL ACETATE, DL-
.BETA.-CAROTENE
ZINC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42291-686	42291-686-01
65162-668

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ASCORBYL PALMITATE	QN83US2B0N	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	O7TSZ97GEP	IACT
.ALPHA.-TOCOPHEROL, DL-	7QWA1RIO01	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STARCH, CORN	O8232NY3SJ	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM ASCORBATE	S033EH8359	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SORBIC ACID	X045WJ989B	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SUCROSE	C151H8M554	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
VITAMIN A ACETATE	3LE3D9D6OY	ACTIM
CYANOCOBALAMIN	P6YC3EG204	ACTIB
ASCORBIC ACID	PQ6CK8PD0R	ACTIB
CHOLECALCIFEROL	1C6V77QF41	ACTIB
FOLIC ACID	935E97BOY8	ACTIB
THIAMINE MONONITRATE	8K0I04919X	ACTIR
RIBOFLAVIN	TLM2976OFR	ACTIB
NIACINAMIDE	25X51I8RD4	ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	ACTIM
.BETA.-CAROTENE	01YAE03M7J	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
CALCIUM CARBONATE	H0G9379FGK	ACTIM
FERROUS FUMARATE	R5L488RY0Q	ACTIM
PYRIDOXINE HYDROCHLORIDE	68Y4CF58BV	ACTIB
CUPRIC OXIDE	V1XJQ704R4	ACTIM
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	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 11 · 659 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, CHEWABLE / ORAL	40 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / RECTAL	0.5 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SHAMPOO / TOPICAL	3 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, EXTENDED RELEASE / ORAL		1229 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 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
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	DROPS / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
.alpha.-tocopherol, Dl-	.ALPHA.-TOCOPHEROL, DL-	7QWA1RIO01	INJECTION, EMULSION / INTRAVENOUS		178 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	SYRUP / ORAL		250 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	SUPPOSITORY / RECTAL		16 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / ORAL	75.3 mg/15ml		Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	GRANULE, FOR SUSPENSION / ORAL	1.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, DELAYED RELEASE / ORAL	0.02 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	ELIXIR / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, EXTENDED RELEASE / ORAL	2.03 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Hypromelloses	HYPROMELLOSE	3NXW29V3WO	GRANULE / ORAL		45 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Calcium Phosphate, Dibasic, Dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	PASTE, DENTIFRICE / DENTAL	51 %w/w		Exact identifier — unii candidate 10 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
d5bf87e1-e9fc-3714-e053-2a95a90af63e			1a58de37-470c-6108-5ba8-1af4a628b97d	2023-03-01	Boxed warning, Warnings	Exact identifier spl set id: 1a58de37-470c-6108-5ba8-1af4a628b97d

Reported adverse events (FAERS/openFDA)#

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