Viva CT

Manufacturer
JayMac Pharmaceuticals LLC | Sancilio
Effective date
2012-05-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:15:11

Label at a glance#

ProductViva CT Prenatal
Active ingredientFOLIC ACID, FERROUS FUMARATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, ZINC OXIDE, CUPRIC SULFATE ANHYDROUS, Selenomethionine
Label structure14 sections

Indications and uses

Viva ® CT Prenatal Chewable is indicated for the distinct nutritional requirements of individuals in need of PRENATAL/POSTNATAL dietary supplementation as determined by a licensed medical practitioner. This product can be used fordietary management prior to conception. Viva ® CT Prenatal Chewable should be administered under the supervision of a licensed medical practitioner.

Dosage and administration

Chew and swallow one tablet daily, or as directed by a licensed medical practitioner.

Storage and handling

Store at Controlled Room Temperature 15°- 30°C (59°- 86°F). [See USP]. Dispense in a tight, light-resistant container.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx Only

30ct round, light pink to pink-colored, fruit-flavored chewable tablets, embossed VCT

Prescription PRENATAL/POSTNATAL Vitamin

DESCRIPTION

DESCRIPTION SECTION

Viva® CT Prenatal Chewable is an orally administered, chewable prescription PRENATAL/POSTNATAL vitamin specifically formulated for the dietary management of individuals with unique nutritional needs requiring increased folate levels. Viva® CT Prenatal Chewable should be administered under the supervision of a licensed medical practitioner.

Each ROUND, LIGHT TO PINK-colored, chewable tablet contains the following dietary ingredients:

Folic Acid1 mg*
Iron (ferrous fumarate)28 mg*
Vitamin C (ascorbic acid)100 mg*
Vitamin D3 (cholecalciferol)400 IU*
Vitamin E (acetate)30 IU*
Vitamin B1 (thiamine mononitrate)3 mg*
Vitamin B2 (riboflavin)3 mg*
Vitamin B6 (pyridoxine HCl)50 mg*
Vitamin B12 (cyanocobalamin)15 mcg*
Zinc (oxide)20 mg*
Copper (sulfate)1 mg*
L-(+)-Selenomethionine† 50 mcg*

* Daily Value not established for individuals with unique nutritional needs who are in need of nutritional supplementation as directed by a licensed medical practitioner.

† L-(+)-Selenomethionine as Selenium SeLECT® is a registered trademark of Sabinsa Corporation, Piscataway, NJ. It has CAS #3211-76-5, and is chemically known as the diasterioisomerically pure (S)-(+)-2-Amino-4(methylseleno)-butanoic acid.

Other Ingredients

SPL UNCLASSIFIED SECTION

Xylitol, Microcrystalline Cellulose, Povidone, Magnesium Stearate, Talc, Fruit Punch Flavor, Sucralose.

FOLATE REGULATION

SPL UNCLASSIFIED SECTION

The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, I-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate. Folic acid, including the reduced forms3 such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision of a licensed medical practitioner.

The 1971, 1972, 1973, 1980, 1984, 2000, and 2010 Federal Register Notices addressed this concern while establishing that increased folate was proper therapy in megaloblastic anemias - specifically where homocysteine levels were elevated or risk of neural tube defects (NTDs) was at issue. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that: Dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription. Folic acid - including reduced forms, may be added to medical foods as defined in section 5(b) (3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345).

3 This product is a dietary supplement that - due to increased folate levels (AUG 3 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of vitamin B12 deficiency. As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Viva® CT Prenatal Chewable is indicated for the distinct nutritional requirements of individuals in need of PRENATAL/POSTNATAL dietary supplementation as determined by a licensed medical practitioner. This product can be used fordietary management prior to conception. Viva® CT Prenatal Chewable should be administered under the supervision of a licensed medical practitioner.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Viva® CT Prenatal Chewable is contraindicated in individuals with a known hypersensitivity to any of the ingredients.

WARNINGS

WARNINGS SECTION

WARNING

BOXED WARNING SECTION

Accidental overdose of iron-containing products is the leading cause of poisoning of 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.

PREGNANCY and NURSING MOTHERS

PREGNANCY SECTION

NURSING MOTHERS SECTION

Viva® CT Prenatal Chewable is intended for use as a PRENATAL/POSTNATAL vitamin for lactating and non-lactating mothers. Talk with your medical practitioner to ensure adequate prenatal/postnatal supplementation. Consult with your licensed medical practitioner before using Viva® CT Prenatal Chewable if pregnant or nursing.

PRECAUTIONS

PRECAUTIONS SECTION

Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

PATIENT INFORMATION

INFORMATION FOR PATIENTS SECTION

Viva® CT Prenatal Chewable is a prescription PRENATAL/POSTNATAL vitamin to be used only under licensed medical supervision.

DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

Drugs which may interact with folate include:

  • Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate.
  • Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among individuals who are receiving treatment with phenytoin and other anticonvulsants.
  • Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.
  • Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.
  • Colestipol: Reduces folic acid absorption and reduces serum folate levels.
  • Cycloserine: Reduces folic acid absorption and reduces serum folate levels.
  • Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.
  • Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.
  • Isotretinoin: Reduced folate levels have occurred in some individuals taking isotretinoin.
  • L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels.
  • Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments.
  • NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.
  • Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.
  • Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.
  • Pancreatic Enzymes: Reduced folate levels have occurred in some individuals taking pancreatic extracts, such as pancreatin and pancrelipase.
  • Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.
  • Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine.
  • Smoking and Alcohol: Reduced serum folate levels have been noted.
  • Sulfasalazine: Inhibits the absorption and metabolism of folic acid.
  • Metformin treatment in individuals with type 2 diabetes decreases serum folate.
  • Warfarin can produce significant impairment in folate status after a 6-month therapy.
  • Heme-iron: Can compete for transport and reduce folate absorption. Ensure adequate medical supervision to ensure proper iron levels.
  • Folinic acid may enhance the toxicity of fluorouracil.
  • Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folate.
  • Caution should be exercised with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study.

**Folate is a broad term that includes folic acid and all reduced forms including I-methylfolate and folinic acid. Viva® CT Prenatal Chewable does not contain I-methylfolate or folinic acid but these warnings are included as general folate information.

Drugs which interact with vitamin B6:

  • Vitamin B6 should not be given to individuals receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6. However, vitamin B6 may be used concurrently in individuals receiving a preparation containing both carbidopa and levodopa.

Drugs which may interact with vitamin B12:

  • Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic acid, and potassium chloride may decrease the absorption of vitamin B12.
  • Nitrous oxide can produce a functional vitamin B12 deficiency.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Allergic sensitization has been reported following both oral and parenteral administration of folate. Paresthesia, somnolence, nausea, and headaches have been reported with vitamin B6. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Chew and swallow one tablet daily, or as directed by a licensed medical practitioner.

STORAGE

STORAGE AND HANDLING SECTION

Store at Controlled Room Temperature 15°- 30°C (59°- 86°F). [See USP]. Dispense in a tight, light-resistant container.

HOW SUPPLIED

HOW SUPPLIED SECTION

Viva® CT Prenatal Chewable is supplied as round, light pink to pink-colored chewable tablets embossed VCT, and are dispensed in bottles of 30 tablets.

NDC3 64661-811-30

SPL UNCLASSIFIED SECTION

Call your medical practitioner about side effects. You may report side effects by calling 866-280-5961.

KEEP THIS OUT OF REACH OF CHILDREN.

Rx Only

All prescriptions using this product shall be pursuant to State statutes as applicable.

Manufactured by: Sancilio & Company, Inc.,
3874 Fiscal Court, Suite 200, Riviera Beach, FL 33404

JAYMAC
Pharmaceuticals, LLC

MADE IN CHINA

REV 4/2012

PRINCIPAL DISPLAY PANEL - 30 Chewable Tablet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx
Patent Protected

30 ct. Fruit-flavored,
Chewable Tablets

Viva®CT
Prenatal Chewable

Manufactured for:
JAYMAC
Pharmaceuticals, LLC

Sunset, LA 70584

Prescription Vitamin
NDC++64661-811-30

PRINCIPAL DISPLAY PANEL - 30 Chewable Tablet Label
PRINCIPAL DISPLAY PANEL - 30 Chewable Tablet Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
COPPER Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64661-811-302020-01-31C16284748780-19d75b9d1-1af4-f424-e053-dadaa90a57ceViva ® CT Prenatal Chewable IRON SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64661-811-30Viva CT Prenatal30 in 1 BOTTLETABLET, CHEWABLE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64661-811VIVA CT PRENATAL (FOLIC ACID, FERROUS FUMARATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, ZINC OXIDE, CUPRIC SULFATE ANHYDROUS, AND SELENOMETHIONINE) TABLET, CHEWABLE [JAYMAC PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20120517_ad02306c-e1a3-441d-825e-d79047c61022.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64661-811-30EA - Each64661-8113e5abbd5-c2dd-45eb-8eb7-fa98494260d412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROL ACETATEACTIVE INGREDIENT9E8X80D2L01
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0R1
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF411
CUPRIC SULFATE ANHYDROUSACTIVE INGREDIENTKUW2Q3U1VV1
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2041
FERROUS FUMARATEACTIVE INGREDIENTR5L488RY0Q1
FOLIC ACIDACTIVE INGREDIENT935E97BOY81
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV1
RIBOFLAVINACTIVE INGREDIENTTLM2976OFR1
SelenomethionineACTIVE INGREDIENT964MRK2PEL1
THIAMINE MONONITRATEACTIVE INGREDIENT8K0I04919X1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
.ALPHA.-TOCOPHEROLACTIVE MOIETYH4N855PNZ11
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0R1
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF411
COPPERACTIVE MOIETY789U1901C51
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2041
FOLIC ACIDACTIVE MOIETY935E97BOY81
IRONACTIVE MOIETYE1UOL152H71
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z1
RIBOFLAVINACTIVE MOIETYTLM2976OFR1
SelenomethionineACTIVE MOIETY964MRK2PEL1
THIAMINEACTIVE MOIETYX66NSO3N351
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POVIDONEINACTIVE INGREDIENTFZ989GH94E1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
TALCINACTIVE INGREDIENT7SEV7J4R1U1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1

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
64661-81164661-811-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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 3 · 166 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE / ORAL2210 mgExact identifier — unii candidate
28 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET / ORAL15.04 mgExact identifier — unii candidate
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL47 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPOWDER, FOR SUSPENSION / ORAL4223 mgExact identifier — unii candidate
12 equally ranked IID candidates
TALCTALC7SEV7J4R1UPELLET / ORAL69 mgExact identifier — unii candidate
35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii candidate
35 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION / ORAL20 mg/5mlExact identifier — unii candidate
30 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPASTE / ORAL180 mgExact identifier — unii candidate
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FOR SUSPENSION / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, COATED PELLETS / ORAL10.03 mgExact identifier — unii candidate
30 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, EXTENDED RELEASE / ORAL2752 mgExact identifier — unii candidate
12 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EINJECTION / INTRAMUSCULAR0.2 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1576 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE PELLETS / ORAL32 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
30 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UIMPLANT / INTRAVITREAL1.66 mgExact identifier — unii candidate
28 equally ranked IID candidates
TALCTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESOLUTION / ORAL21600 mgExact identifier — unii candidate
12 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / TRANSMUCOSAL100 mgExact identifier — unii candidate
39 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / SUBLINGUAL43.2 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING / ORAL1800 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EIMPLANT / SUBCUTANEOUS6 mgExact identifier — unii candidate
30 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SPRAY, METERED / NASAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30LOZENGE / ORAL420 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FOR SUSPENSION / ORAL131 mgExact identifier — unii candidate
39 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii candidate
30 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EFFERVESCENT / ORAL1080 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii candidate
28 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, DELAYED RELEASE PARTICLES / ORAL56 mgExact identifier — unii candidate
35 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, EXTENDED RELEASE / ORAL117 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SOLUTION / ORAL690 mgExact identifier — unii candidate
28 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SUSPENSION, EXTENDED RELEASE / ORAL16 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, DELAYED RELEASE / ORAL789.6 mgExact identifier — unii candidate
28 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, CHEWABLE / ORAL28 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii candidate
35 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b55156d3-2850-423a-ab3e-f6db662afbdcad02306c-e1a3-441d-825e-d79047c610222012-05-03Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: b55156d3-2850-423a-ab3e-f6db662afbdc
spl set id: ad02306c-e1a3-441d-825e-d79047c61022

Reported adverse events (FAERS/openFDA)#

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