Clemastine Fumarate

Manufacturer
Carilion Materials Management
Effective date
2012-04-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:39:42

Label at a glance#

ProductClemastine Fumarate
Active ingredientCLEMASTINE FUMARATE
Label structure9 sections

Indications and uses

Temporarily relieves these symptoms of the common cold, hay fever, or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

Dosage and administration

adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clemastine fumarate 1.34 mg (equivalent to 1 mg clemastine)

Purpose

OTC - PURPOSE SECTION

Antihistamine

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.

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms of the common cold, hay fever, or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

aska health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and older:

1 tablet every 12 hours; not more than 2 tablets in 24 hours

children under 12 years:

ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • Safety sealed: do not use if the imprinted bottle seal is open or torn.
  • Store at 20°-25°C (68°-77°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and starch (corn).

Questions or comments?

OTC - QUESTIONS SECTION

1-800-525-8747

Clemastine Fumarate 1.34 MG TAB

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
857416clemastine fumarate 1.34 MG Oral TabletPSN2
857416clemastine fumarate 1.34 MG Oral TabletSCD2
857416clemastine fumarate 1.34 MG (clemastine 1 MG) Oral TabletSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f7e17947-a18d-ce47-e13b-48f8b11c0c6fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-2456-02020-01-31C16284748780-19d75b9d0-4735-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-2456-0Clemastine Fumarate1 in 1 PACKAGETABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-2456CLEMASTINE FUMARATE TABLET [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140708_74f3a9fb-c35e-4720-9538-0a0afe0a773d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1358-01EA - Each0781-135897e7426a-b454-4762-935c-bf604f5dea0812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CLEMASTINE FUMARATEACTIVE INGREDIENT19259EGQ3D2
CLEMASTINEACTIVE MOIETY95QN29S1ID2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY822
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5X2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A22
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68151-245668151-2456-0
0781-1358

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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 · 142 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XCAPSULE / ORAL3990 mgExact identifier — unii candidate
38 equally ranked IID candidates
HYPROMELLOSE 2910 (3 MPA.S)HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82SUSPENSION / ORAL156 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET, EXTENDED RELEASE / ORAL2575 mgExact identifier — unii candidate
38 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL21 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTROCHE / ORAL300 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS750 mgExact identifier — unii candidate
38 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FOR SUSPENSION / ORAL131 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, COATED PELLETS / ORAL456 mgExact identifier — unii candidate
28 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR150 mgExact identifier — unii candidate
38 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET, ORALLY DISINTEGRATING / ORAL366 mgExact identifier — unii candidate
38 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET, FOR SUSPENSION / ORAL2794 mgExact identifier — unii candidate
38 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPELLET / ORAL1140 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / SUBLINGUAL505 mgExact identifier — unii candidate
38 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET, COATED / ORAL1301 mgExact identifier — unii candidate
38 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii candidate
28 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
38 equally ranked IID candidates
HYPROMELLOSE 2910 (3 MPA.S)HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
15 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING / ORAL1800 mgExact identifier — unii candidate
28 equally ranked IID candidates
HYPROMELLOSE 2910 (3 MPA.S)HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82CAPSULE, EXTENDED RELEASE / ORAL105 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPASTILLE / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
HYPROMELLOSE 2910 (3 MPA.S)HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82TABLET, EXTENDED RELEASE / ORAL231 mgExact identifier — unii candidate
15 equally ranked IID candidates
HYPROMELLOSE 2910 (3 MPA.S)HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82CAPSULE / ORAL400 mgExact identifier — unii candidate
15 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJSUSPENSION / ORAL900 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, FOR SUSPENSION / ORAL278 mgExact identifier — unii candidate
28 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii candidate
38 equally ranked IID candidates
HYPROMELLOSE 2910 (3 MPA.S)HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82TABLET, DELAYED RELEASE / ORAL140 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FOR SUSPENSION / ORAL20100 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, DELAYED RELEASE / ORAL144 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / BUCCAL16.6 mgExact identifier — unii candidate
22 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XINSERT / VAGINAL2282 mgExact identifier — unii candidate
38 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYPROMELLOSE 2910 (3 MPA.S)HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82GRANULE, FOR SUSPENSION / ORAL1 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XGRANULE, FOR SUSPENSION / ORALNAExact identifier — unii candidate
38 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, EXTENDED RELEASE / ORAL1246 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYPROMELLOSE 2910 (3 MPA.S)HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82TABLET / ORAL570 mgExact identifier — unii candidate
15 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJINSERT / VAGINAL147 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
HYPROMELLOSE 2910 (3 MPA.S)HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82TABLET, ORALLY DISINTEGRATING / ORAL52 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / SUBLINGUAL409 mgExact identifier — unii candidate
22 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY47.5 mgExact identifier — unii candidate
38 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS214 mgExact identifier — unii candidate
38 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL47 mgExact identifier — unii candidate
39 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 44.

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
A073458-001CLEMASTINE FUMARATECLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31c2088c7a36db…
2026-09-14 22:38:342026-08A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-3184e616aacf4f…
2026-08-18 06:07:402026-07A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-313f01610625f2…
2019-09-15 20:21 UTC2019-09A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073458-001CLEMASTINE FUMARATE1.34MGTABLET / ORAL1993-10-313a93d1ddd44b…

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
0381b7d6-b261-4c91-9399-bb31be8aa41d74f3a9fb-c35e-4720-9538-0a0afe0a773d2012-04-09WarningsExact identifier
spl id: 0381b7d6-b261-4c91-9399-bb31be8aa41d
spl set id: 74f3a9fb-c35e-4720-9538-0a0afe0a773d

Reported adverse events (FAERS/openFDA)#

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