FDA.reportPublic FDA data

Loratadine and Pseudoephedrine Sulfate

Manufacturer
REMEDYREPACK INC.
Effective date
2023-01-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:38:37

Label at a glance#

ProductLoratadine and Pseudoephedrine Sulfate
Active ingredientLORATADINE, PSEUDOEPHEDRINE SULFATE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itchy, watery eyes runny nose itching of the nose or throat reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily restores freer breathing through the nose

Dosage and administration

do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

USES

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • itchy, watery eyes
    • runny nose
    • itching of the nose or throat
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily restores freer breathing through the nose

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
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed.

OTC - WHEN USING SECTION

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.
  • symptoms do not improve within 7 days or are accompanied by a fever
  • nervousness, dizziness or sleeplessness occurs

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

  • do not divide, crush, chew or dissolve the tablet
adults and children 12 years and over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
children under 12 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • sodium: contains 10 mg/tablet
  • calcium: contains 25 mg/tablet
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/labels only)
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)
  • store between 20° C to 25° C (68° F to 77° F).
  • protect from light and store in a dry place

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

SPL UNCLASSIFIED SECTION

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Loratadine and Pseudoephedrine Sulfate

GENERIC: Loratadine and Pseudoephedrine Sulfate

DOSAGE: TABLET, FILM COATED, EXTENDED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-0371-0

NDC: 70518-0371-1

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 17 mm

IMPRINT: RX724

PACKAGING: 15 in 1 BLISTER PACK

PACKAGING: 5 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • PSEUDOEPHEDRINE SULFATE 240mg in 1
  • LORATADINE 10mg in 1

INACTIVE INGREDIENT(S):

  • TITANIUM DIOXIDE
  • SODIUM CITRATE, UNSPECIFIED FORM
  • SODIUM ALGINATE
  • SHELLAC
  • PROPYLENE GLYCOL
  • STARCH, CORN
  • POVIDONE, UNSPECIFIED
  • TALC
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • MAGNESIUM STEARATE
  • LACTOSE MONOHYDRATE
  • FERROSOFERRIC OXIDE
  • HYPROMELLOSE, UNSPECIFIED
  • HYDROXYPROPYL CELLULOSE (1600000 WAMW)
  • SILICON DIOXIDE
  • MICROCRYSTALLINE CELLULOSE
  • CALCIUM CARBONATE

MM1MM1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5833-15EA - Each0904-5833bd9c7ac0-0053-445f-92b5-4e127fdfd48112013-02-13
0904-5833-48EA - Each0904-583348b45c9f-2888-4c08-99d6-d197b64e59cc12013-02-13

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-037170518-0371-0, 70518-0371-1
0904-5833

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)RFW2ET671PIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LORATADINE7AJO3BO7QNACTIB
PSEUDOEPHEDRINE SULFATEY9DL7QPE6BACTIB

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
A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2284e616aacf4f…
2026-08-18 06:07:402026-07A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-223f01610625f2…
2019-09-15 20:21 UTC2019-09A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076557-001LORATADINE AND PSEUDOEPHEDRINE SULFATE10MG;240MGTABLET, EXTENDED RELEASE / ORAL2004-09-22f41ea6bd6efb…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEMajor Pharmaceuticals2620a150-4a2c-4fa2-a0e4-6aafe9e496c32025-09-08WarningsExact identifier
ndc (product): 0904-5833
079c14ed-faee-3c07-e063-6394a90ad8736cc91178-bfde-4cbf-a3e0-1124ab5ff86a2023-10-13WarningsExact identifier
spl set id: 6cc91178-bfde-4cbf-a3e0-1124ab5ff86a

Reported adverse events (FAERS/openFDA)#

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