FDA.reportPublic FDA data

Fexofenadine HCl 60 mg and Pseudoephedrine HCI 120 mg ER Tablets USP

Manufacturer
CVS Pharmacy
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
legacy-cache
Hydrated at
2026-08-01 20:51:03

Label at a glance#

ProductFexofenadine HCl and Pseudoephedrine HCI
Active ingredientFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure11 sections

Dosage and administration

do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over   take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours children under 12 years of age do not use Adults 65 years of age  and older ask a doctor consumers with kidney disease ask a doctor

Storage and handling

store between 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Fexofenadine HCl USP, 60 mg

Pseudoephedrine HCl USP,120 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

Use(s)

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • nasal congestion
  • itchy, watery eyes
  • itching of the nose or throat
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • 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.
  • if you have difficulty swallowing

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • thyroid disease
  • glaucoma
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • 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
  • do not take at the same time as aluminum or magnesium antacids
  • do not take with fruit juices (see Directions)
  • the tablet coating may be seen in the stool (this is normal). Continue to takeas directed (see Directions).

Stop use and ask 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
  • you get nervous, dizzy, or sleepless

Pregnancy/Breastfeeding

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 contacta Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not divide, crush, chew or dissolve the tablet; swallow tablet whole
adults and children 12 years of age and over   take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
children under 12 years of agedo not use
Adults 65 years of age  and olderask a doctor
consumers with kidney diseaseask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • safety sealed: do not use if carton is opened or if individual blister units are torn or opened
  • this product meets the requirements of USP dissolution test 3.

Storage

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose, and triethyl citrate.

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

Carton label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-249FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]16Legacy NDC20241030_d106f6b3-36df-e926-c298-b030dc79dbe6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-447-07EA - Each55111-4474f58ccdb-d761-4c3b-bca7-2808bbe17d4d12022-06-06
55111-447-14EA - Each55111-4471597fd92-2bcd-4f33-bb6e-3f88105cea9e12015-09-10

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-24969842-249-20, 69842-249-30
55111-447

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
FEXOFENADINE HYDROCHLORIDE2S068B75ZUACTIB
MANNITOL3OWL53L36AIACT
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
POWDERED CELLULOSESMD1X3XO9MIACT
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FERRIC OXIDE RED1K09F3G675IACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSES3NXW29V3WOIACT
TRIETHYL CITRATE8Z96QXD6UMIACT

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
A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18

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 22:38:342026-08A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-1884e616aacf4f…
2026-08-18 06:07:402026-07A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-183f01610625f2…
2019-09-15 20:21 UTC2019-09A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18f41ea6bd6efb…

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
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIDr. Reddy's Laboratories Limited728632be-7e5c-2d06-4c95-bc8ecc9be2ec2024-12-19WarningsExact identifier
ndc (product): 55111-447
faa638a3-ddfa-3626-d986-27bc31701c6cd106f6b3-36df-e926-c298-b030dc79dbe62024-10-28WarningsExact identifier
spl set id: d106f6b3-36df-e926-c298-b030dc79dbe6

Reported adverse events (FAERS/openFDA)#

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