Harris Teeter Allergy and Congestion Relief

Manufacturer
Harris Teeter, LLC
Effective date
2020-11-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:07:21

Label at a glance#

ProductHarris Teeter Allergy and Congestion Relief
Active ingredientLORATADINE, PSEUDOEPHEDRINE SULFATE
Label structure14 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 • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through...

Dosage and administration

• do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets 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 5 mg

Pseudoephedrine sulfate 120 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
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily restores freer breathing through the nose

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 over

1 tablet every 12 hours; not more than 2 tablets in 24 hours

children under 12 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 25 mg
  • do not use if blister unit is broken or torn
  • store between 20° to 25°C (68° to 77°F)
  • keep in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy & Congestion Relief

Compare to the active ingredients in Claritin-D® 12 hour Extended Release Tablets

Pseudoephedrine Sulfate 120 mg/ Nasal Decongestant

Loratadine 5 mg/Antihistamine Extended Release Tablets

INDOOR & OUTDOOR ALLERGIES

Non-Drowsy*

12 Hour

Relief of:

Nasal and Sinus Congestion Due to Colds or Allergies

Sneezing - Runny Nose - Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

Actual Size

20 TABLETS

*When taken as directed. See Drug Facts Panel.

allergy and congestion relief image
allergy and congestion relief image

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69256-257HARRIS TEETER ALLERGY AND CONGESTION RELIEF (LORATADINE, PSEUDOEPHEDRINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [HARRIS TEETER, LLC]3Legacy NDC20201114_c33b7870-e4f9-4e28-a619-606621a43bd3.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69256-25769256-257-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30

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 22:38:342026-08A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-3084e616aacf4f…
2026-08-18 06:07:402026-07A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-303f01610625f2…
2019-09-15 20:21 UTC2019-09A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076050-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2003-01-30f41ea6bd6efb…

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
05d96f46-1888-499a-9f4a-90dc16140d31c33b7870-e4f9-4e28-a619-606621a43bd32025-07-03WarningsExact identifier
spl set id: c33b7870-e4f9-4e28-a619-606621a43bd3

Reported adverse events (FAERS/openFDA)#

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