Kmart Corporation Famotidine Tablets Drug Facts

Manufacturer
Kmart Corporation
Effective date
2016-01-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:29:22

Label at a glance#

Productsmart sense famotidine
Active ingredientFAMOTIDINE
Label structure9 sections

Indications and uses

• relieves heartburn associated with acid indigestion and sour stomach • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Dosage and administration

• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. • to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn • do not use more than 2 tablets in 24 hours • children under 12 years: ask a doctor

Storage and handling

• read the directions and warnings before use • keep the carton. It contains important information. • store at 20°-25°C (68°-77°F) • protect from moisture and light

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine 10 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use

OTC - DO NOT USE SECTION

  • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  • with other acid reducers

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • had heartburn over 3 months. This may be a sign of a more serious condition.
  • heartburn with lightheadedness, sweating, or dizziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over:
  • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
  • to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn
  • do not use more than 2 tablets in 24 hours
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20°-25°C (68°-77°F)
  • protect from moisture and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, talc, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENT IN ORIGINAL STRENGTH PEPCID® AC TABLETS

ACTUAL SIZE

ORIGINAL STRENGTH

famotidine TABLETS 10 mg

ACID REDUCER

JUST ONE TABLET:

prevents & relieves heartburn due to acid indigestion

30 TABLETS

10 mg EACH

Smart Sense Famotidine Image 1
Smart Sense Famotidine Image 1
Smart Sense Famotidine Image 2
Smart Sense Famotidine Image 2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z81
FAMOTIDINEACTIVE MOIETY5QZO15J2Z81
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IE1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TRIACETININACTIVE INGREDIENTXHX3C3X6731

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49738-20149738-201-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 4 · 238 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673CAPSULE, EXTENDED RELEASE / ORAL467 mgExact identifier — unii candidate
14 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, EXTENDED RELEASE / ORAL117 mgExact identifier — unii candidate
39 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION, EXTENDED RELEASE / ORAL46 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SOLUTION / ORAL690 mgExact identifier — unii candidate
28 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673CAPSULE, DELAYED RELEASE / ORAL5.1 mgExact identifier — unii candidate
14 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE / ORAL14 mgExact identifier — unii candidate
20 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, FILM COATED / ORAL15.12 mgExact identifier — unii candidate
14 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTSUSPENSION / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii candidate
28 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED / ORAL91 mgExact identifier — unii candidate
35 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii candidate
20 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii candidate
3 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZCAPSULE / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
21 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGEL / RECTAL348 mgExact identifier — unii candidate
27 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii candidate
40 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / ORAL305 mgExact identifier — unii candidate
27 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET, EXTENDED RELEASE / ORAL22 mgExact identifier — unii candidate
3 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673CONCENTRATE / ORAL250 mgExact identifier — unii candidate
14 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, DELAYED RELEASE / ORAL37 mgExact identifier — unii candidate
21 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE PARTICLES / ORAL580 mgExact identifier — unii candidate
28 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
39 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, CHEWABLE / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii candidate
28 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, EXTENDED RELEASE / ORAL15 mgExact identifier — unii candidate
20 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, ORALLY DISINTEGRATING / ORAL41 mgExact identifier — unii candidate
27 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZGUM, CHEWING / BUCCAL10 mgExact identifier — unii candidate
11 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
11 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, EXTENDED RELEASE / ORAL26 mgExact identifier — unii candidate
14 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE / ORAL45 mgExact identifier — unii candidate
27 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOINSERT / VAGINAL54.21 mgExact identifier — unii candidate
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET, COATED / ORAL1 mgExact identifier — unii candidate
14 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UPELLET / ORAL69 mgExact identifier — unii candidate
35 equally ranked IID candidates

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075400-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2005-03-18

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1884e616aacf4f…
2026-08-18 06:07:402026-07A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-183f01610625f2…
2019-09-15 20:21 UTC2019-09A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18f41ea6bd6efb…

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
57eb6621-1fa3-44a0-966b-a640999783acc60681ee-e262-4340-b516-031f8317561b2019-12-16WarningsExact identifier
spl set id: c60681ee-e262-4340-b516-031f8317561b

Reported adverse events (FAERS/openFDA)#

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