Sunmark ® children's loratadine syrup

Manufacturer
McKesson | Taro Pharmaceuticals U.S.A., Inc. | Taro Pharmaceutical Industries Ltd.
Effective date
2012-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:33:40

Label at a glance#

ProductSunmark childrens loratadine
Active ingredientLoratadine
Label structure11 sections

Indications and uses

temporarily relieves these symptoms due to 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 6 years and over 2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours children 2 to under 6 years of age 1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours consumers with liver or kidney disease ask a doctor

Storage and handling

safety sealed: do not use if imprinted safety seal is torn or missing store between 2° and 25°C (36° and 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - WHEN USING SECTION

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and over2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
children 2 to under 6 years of age1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
consumers with liver or kidney diseaseask a doctor

Other information

STORAGE AND HANDLING SECTION

  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 2° and 25°C (36° and 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by McKesson
One Post Street, San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunmark®

COMPARE TO
CHILDREN'S CLARITIN®
ACTIVE INGREDIENT*

NDC 49348 849-34

24 HOUR
ALLERGY RELIEF

children's
loratadine
syrup

(Loratadine Oral Solution)
5 mg/5 mL Antihistamine

Relief of
sneezing, runny nose
itchy, watery eyes
itchy throat or nose

Dye Free
Non-drowsy†
Ages two years & older

GRAPE FLAVOR

4 FL OZ (120 mL)

† When taken as directed. See Drug Facts Panel.

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
692783loratadine 5 MG in 5 mL Oral SolutionPSN1
692783loratadine 1 MG/ML Oral SolutionSCD1
692783loratadine 5 MG per 5 ML Oral SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49348-849-342020-01-31C16284748780-19d75b9d0-0f0a-f424-e053-dadaa90a57ceSunmark ® children's loratadine syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-849-34Sunmark childrens loratadine1 in 1 CARTONSOLUTION11
49348-849-34Sunmark childrens loratadine120 mL in 1 BOTTLESOLUTION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-849SUNMARK CHILDRENS LORATADINE (LORATADINE) SOLUTION [MCKESSON]1Legacy NDC, 2 package rows20121114_775731a2-9b30-4a0e-82fb-b517b36317c7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-849-34ML - Milliliter49348-849d9d8e2c1-83f1-4bc1-b560-12c9fe71392f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QN1
LoratadineACTIVE MOIETY7AJO3BO7QN1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QP1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
propylene glycolINACTIVE INGREDIENT6DC9Q167V31
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU1
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3C1
sucroseINACTIVE INGREDIENTC151H8M5541
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49348-84949348-849-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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 7 · 370 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
sucroseSUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii candidate
35 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO, SUSPENSION / TOPICAL0.25 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
sucroseSUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii candidate
35 equally ranked IID candidates
sucroseSUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CINJECTION / INTRALESIONAL0.1 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPFILM, EXTENDED RELEASE / TRANSDERMAL1.38 mgExact identifier — unii candidate
88 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION, CONCENTRATE / INTRAVENOUSNAExact identifier — unii candidate
88 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPOINTMENT / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CCAPSULE / ORAL0.36 mgExact identifier — unii candidate
43 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPDOUCHE / VAGINAL0.07 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, EFFERVESCENT / ORAL460 mgExact identifier — unii candidate
88 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUINJECTION / INTRAVENOUS864 mgExact identifier — unii candidate
35 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
sucroseSUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii candidate
48 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SUSPENSION / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / EPIDURAL0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / RESPIRATORY (INHALATION)0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
sucroseSUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CINJECTION / EPIDURAL0.05 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPCREAM / VAGINAL0.49 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CSUSPENSION, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
43 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
sucroseSUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
citric acid monohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
sucroseSUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
sucroseSUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 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
A076805-001LORATADINELORATADINE1MG/MLSYRUP / ORAL2004-08-20

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 13:18:302026-09A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20c2088c7a36db…
2026-09-14 22:38:342026-08A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2084e616aacf4f…
2026-08-18 06:07:402026-07A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203f01610625f2…
2019-09-15 20:21 UTC2019-09A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076805-001LORATADINE1MG/MLSYRUP / ORAL2004-08-203a93d1ddd44b…

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
492e6c04-e1a4-41a4-9090-bfe010609c90775731a2-9b30-4a0e-82fb-b517b36317c72012-11-12WarningsExact identifier
spl id: 492e6c04-e1a4-41a4-9090-bfe010609c90
spl set id: 775731a2-9b30-4a0e-82fb-b517b36317c7

Reported adverse events (FAERS/openFDA)#

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