Dr Simi All Day Allergy Relief

Manufacturer
Farmacias De Similares TX LLC | Granules India Limited
Effective date
2026-02-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:47:40

Label at a glance#

ProductDr Simi All Day Allergy Relief
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 1 caplet daily; not more than 1 caplet in 24 hours Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

  • Loratadine 10 mg

Purpose

OTC - PURPOSE SECTION

Purpose

  • 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

Warnings

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

OTC - WHEN USING SECTION

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.

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

Keep out of reach of children

Overdosage

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years and over1 caplet daily; not more than 1 caplet in 24 hours
Children under 6 years of ageAsk a doctor
Consumers with liver or kidney diseaseAsk a doctor

Other information

OTHER SAFETY INFORMATION

  • Store between 20° to 25°C (68° to 77°F).
  • Protect from exessive moisture.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Lactose monohydrate, Magnesium stearate, Pregelatinized starch (maize), Sodium starch glycolate.

Questions or comments?

OTC - QUESTIONS SECTION

(855)-280-1079

SPL UNCLASSIFIED SECTION

Distributed by: FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA.
customerservice@drsimi.com
www.drsimi.com

LOT#

EXP:

PEEL BACK for more DRUG FACTS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DR SIMI

NDC 85786-201-90

NON-DROWSY*

Allergy Relief

Loratadine 10 mg

Antihistamine

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

100 Caplets

24 Hour Allergy Relief

Original prescription strength

Principal display panelPrincipal display panel

Tabla drug factsTabla drug facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311372loratadine 10 MG 24HR Oral TabletPSN2
311372loratadine 10 MG Oral TabletSCD2
311372loratadine 10 MG 24 HR Oral TabletSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850072692869GTIN-13: 0850072692869
EAN-13: 0850072692869
GTIN-12: 850072692869
UPC-A: 850072692869
GTIN storage (14 digits): 00850072692869
Principal Display Panel 10.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85786-201-90Dr Simi All Day Allergy Relief100 in 1 BOTTLETABLET, FILM COATED1002

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85786-20185786-201-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

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
A210722-001LORATADINELORATADINE10MGTABLET / ORAL2019-12-23

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210722-001LORATADINE10MGTABLET / ORAL2019-12-2384e616aacf4f…
2026-08-18 06:07:402026-07A210722-001LORATADINE10MGTABLET / ORAL2019-12-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210722-001LORATADINE10MGTABLET / ORAL2019-12-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A210722-001LORATADINE10MGTABLET / ORAL2019-12-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210722-001LORATADINE10MGTABLET / ORAL2019-12-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210722-001LORATADINE10MGTABLET / ORAL2019-12-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210722-001LORATADINE10MGTABLET / ORAL2019-12-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210722-001LORATADINE10MGTABLET / ORAL2019-12-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210722-001LORATADINE10MGTABLET / ORAL2019-12-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210722-001LORATADINE10MGTABLET / ORAL2019-12-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210722-001LORATADINE10MGTABLET / ORAL2019-12-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210722-001LORATADINE10MGTABLET / ORAL2019-12-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210722-001LORATADINE10MGTABLET / ORAL2019-12-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210722-001LORATADINE10MGTABLET / ORAL2019-12-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210722-001LORATADINE10MGTABLET / ORAL2019-12-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210722-001LORATADINE10MGTABLET / ORAL2019-12-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210722-001LORATADINE10MGTABLET / ORAL2019-12-234b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210722-001LORATADINE10MGTABLET / ORAL2019-12-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210722-001LORATADINE10MGTABLET / ORAL2019-12-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A210722-001LORATADINE10MGTABLET / ORAL2019-12-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210722-001LORATADINE10MGTABLET / ORAL2019-12-23c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210722-001LORATADINE10MGTABLET / ORAL2019-12-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210722-001LORATADINE10MGTABLET / ORAL2019-12-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210722-001LORATADINE10MGTABLET / ORAL2019-12-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210722-001LORATADINE10MGTABLET / ORAL2019-12-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210722-001LORATADINE10MGTABLET / ORAL2019-12-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210722-001LORATADINE10MGTABLET / ORAL2019-12-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210722-001LORATADINE10MGTABLET / ORAL2019-12-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A210722-001LORATADINE10MGTABLET / ORAL2019-12-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A210722-001LORATADINE10MGTABLET / ORAL2019-12-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210722-001LORATADINE10MGTABLET / ORAL2019-12-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210722-001LORATADINE10MGTABLET / ORAL2019-12-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210722-001LORATADINE10MGTABLET / ORAL2019-12-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210722-001LORATADINE10MGTABLET / ORAL2019-12-23cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210722-001LORATADINE10MGTABLET / ORAL2019-12-23a50c72e98297…

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
Dr Simi All Day Allergy ReliefLORATADINEFarmacias De Similares TX LLC3c5b2eaa-24da-3314-e063-6294a90a5b212026-02-26WarningsExact identifier
ndc (package): 85786-201-90
ndc (product): 85786-201
ndc11 (package): 85786020190
spl id: 4bc22783-728e-6425-e063-6394a90aac97
spl set id: 3c5b2eaa-24da-3314-e063-6294a90a5b21

Reported adverse events (FAERS/openFDA)#

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