sunmark

Manufacturer
McKesson | Taro Pharmaceuticals U.S.A., Inc.
Effective date
2015-08-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:43:22

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

use only with enclosed dosing cup adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours children under 2 years of age ask a doctor 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 20° and 25°C (68° and 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

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.

OTC - STOP USE SECTION

Stop use and ask a doctor if 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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only with enclosed dosing cup
adults and children 6 years and over2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of ageask a doctor
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 20° and 25°C (68° and 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium phosphate monobasic dihydrate, sucralose powder.

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 49348-333-34

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

SUGAR FREE
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 SolutionPSN2
692783loratadine 1 MG/ML Oral SolutionSCD2
692783loratadine 5 MG per 5 ML Oral SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49348-333-342020-01-31C16284748780-19d75b9cf-f5c0-f424-e053-dadaa90a57cesunmark ® Children's Loratadine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-333-34sunmark Childrens Loratadine120 mL in 1 BOTTLESOLUTION1202
49348-333-34sunmark Childrens Loratadine1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-333SUNMARK CHILDRENS LORATADINE (LORATADINE) SOLUTION [MCKESSON]2Legacy NDC, 2 package rows20150821_0cd1a8be-4184-4534-99f9-0fcc0dcc5224.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-333-34ML - Milliliter49348-3336cb997be-0a79-4ddd-95a4-ea2f37eb8a7612013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LoratadineACTIVE INGREDIENT7AJO3BO7QN2
LoratadineACTIVE MOIETY7AJO3BO7QN2
glycerinINACTIVE INGREDIENTPDC6A3C0OX2
phosphoric acidINACTIVE INGREDIENTE4GA8884NN2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1A2
propylene glycolINACTIVE INGREDIENT6DC9Q167V32
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU2
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3C2
sodium phosphate, monobasic, dihydrateINACTIVE INGREDIENT5QWK6659562
sorbitolINACTIVE INGREDIENT506T60A25R2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49348-33349348-333-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 6 · 319 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CINJECTION, SOLUTION / INTRAMUSCULAR96 mgExact identifier — unii candidate
43 equally ranked IID candidates
sodium phosphate, monobasic, dihydrateSODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION / INTRAVENOUS12.8 mgExact identifier — unii candidate
13 equally ranked IID candidates
sorbitolSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNAEROSOL, FOAM / VAGINALNAExact identifier — unii candidate
28 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CSOLUTION / RESPIRATORY (INHALATION)0.3 %w/wExact identifier — unii candidate
43 equally ranked IID candidates
sorbitolSORBITOL506T60A25RAEROSOL, FOAM / TOPICAL4.95 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CSUSPENSION / ORAL40 mgExact identifier — unii candidate
43 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRAVENOUS1276 mgExact identifier — unii candidate
44 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNTABLET / ORAL0.04 mgExact identifier — unii candidate
28 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUGEL / TOPICAL5 mgExact identifier — unii candidate
35 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION, SOLUTION / INTRAVENOUS4050 mgExact identifier — unii candidate
44 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CSYRUP / ORAL80 mgExact identifier — unii candidate
43 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CINJECTION / PERINEURAL0.05 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CSYSTEM / IONTOPHORESIS0.5 mgExact identifier — unii candidate
43 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CINJECTION / SUBMUCOSAL5 mgExact identifier — unii candidate
43 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CSOLUTION / ORAL640 mgExact identifier — unii candidate
43 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CINJECTION, SOLUTION / INFILTRATION0.05 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
sodium phosphate, monobasic, dihydrateSODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956SOLUTION / OPHTHALMIC2 mgExact identifier — unii candidate
13 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CTABLET / ORAL8 mgExact identifier — unii candidate
43 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
sorbitolSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
sorbitolSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
phosphoric acidPHOSPHORIC ACIDE4GA8884NNINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
sodium phosphate, monobasic, dihydrateSODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS1.6 mgExact identifier — unii candidate
13 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
sodium metabisulfiteSODIUM METABISULFITE4VON5FNS3CINJECTION / INTRALESIONAL0.1 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 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
42c6a214-9cc6-4939-806c-42d8d33cfdcc0cd1a8be-4184-4534-99f9-0fcc0dcc52242015-08-07WarningsExact identifier
spl id: 42c6a214-9cc6-4939-806c-42d8d33cfdcc
spl set id: 0cd1a8be-4184-4534-99f9-0fcc0dcc5224

Reported adverse events (FAERS/openFDA)#

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