American Sales Company Allergy Relief 24 Hour Drug Facts

Manufacturer
American Sales Company
Effective date
2026-07-01
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
weekly-update
Hydrated at
2026-07-17 21:42:22

Label at a glance#

ProductCareOne Allergy Relief 24 Hour
Active ingredientLORATADINE
Label structure9 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 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

• do not use if printed foil under cap is broken or missing • store between 20 ° to 25 ° C (68 ° to 77 ° F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 10 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

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

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 6 years and over

1 tablet daily; not more than 1 tablet in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • do not use if printed foil under cap is broken or missing
  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BONUS SIZE | 33% MORE

Compare to the active ingredient in Claritin®

24hr

ORIGINAL PRESCRIPTION STRENGTH

Non-Drowsy*

Allergy Relief

Loratadine Tablets, 10 mg

Antihistamine

Actual Size

40 TABLETS

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat Or Nose

OUR PHARMACISTS RECOMMEND

*When taken as directed.

See Drug Facts Panel.

612OF-allergy-relief.jpg
612OF-allergy-relief.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QN6
LORATADINEACTIVE MOIETY7AJO3BO7QN6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5X6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I306
POVIDONESINACTIVE INGREDIENTFZ989GH94E6

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122026-02-04full-release2026-06-01 01:37:00
112025-12-18monthly-update2026-06-03 17:46:13

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 1 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
12 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
A076301-001LORATADINELORATADINE10MGTABLET / ORAL2004-06-25

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 13:18:302026-09A076301-001LORATADINE10MGTABLET / ORAL2004-06-25c2088c7a36db…
2026-09-14 22:38:342026-08A076301-001LORATADINE10MGTABLET / ORAL2004-06-2584e616aacf4f…
2026-08-18 06:07:402026-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076301-001LORATADINE10MGTABLET / ORAL2004-06-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076301-001LORATADINE10MGTABLET / ORAL2004-06-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076301-001LORATADINE10MGTABLET / ORAL2004-06-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076301-001LORATADINE10MGTABLET / ORAL2004-06-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076301-001LORATADINE10MGTABLET / ORAL2004-06-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076301-001LORATADINE10MGTABLET / ORAL2004-06-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076301-001LORATADINE10MGTABLET / ORAL2004-06-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-253f01610625f2…
2019-09-15 20:21 UTC2019-09A076301-001LORATADINE10MGTABLET / ORAL2004-06-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076301-001LORATADINE10MGTABLET / ORAL2004-06-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076301-001LORATADINE10MGTABLET / ORAL2004-06-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076301-001LORATADINE10MGTABLET / ORAL2004-06-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076301-001LORATADINE10MGTABLET / ORAL2004-06-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076301-001LORATADINE10MGTABLET / ORAL2004-06-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076301-001LORATADINE10MGTABLET / ORAL2004-06-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A076301-001LORATADINE10MGTABLET / ORAL2004-06-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A076301-001LORATADINE10MGTABLET / ORAL2004-06-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076301-001LORATADINE10MGTABLET / ORAL2004-06-253a93d1ddd44b…

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
CareOne Allergy Relief 24 HourLORATADINEAmerican Sales Companybbd5424f-fa5b-4955-8542-7011b19400ea2026-07-01WarningsExact identifier
ndc (package): 41520-612-46
ndc (package): 41520-612-03
ndc (package): 41520-612-65
ndc (package): 41520-612-82
ndc (package): 41520-612-95
ndc (package): 41520-612-72
ndc (package): 41520-612-60
ndc (package): 41520-612-76
ndc (package): 41520-612-75
ndc (package): 41520-612-78
ndc (package): 41520-612-58
ndc (product): 41520-612
ndc11 (package): 41520061272
ndc11 (package): 41520061260
ndc11 (package): 41520061246
ndc11 (package): 41520061203
ndc11 (package): 41520061258
ndc11 (package): 41520061276
ndc11 (package): 41520061278
ndc11 (package): 41520061275
ndc11 (package): 41520061295
ndc11 (package): 41520061282
ndc11 (package): 41520061265
spl id: 0a1c2126-c09e-4f8c-9aad-6e1aaf8bb4e7
spl set id: bbd5424f-fa5b-4955-8542-7011b19400ea

Reported adverse events (FAERS/openFDA)#

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