FDA.reportPublic FDA data

Leader All Day Sinus and Cold D

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2025-04-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:59:52

Label at a glance#

ProductLeader All Day Sinus and Cold D
Active ingredientNAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these cold, sinus, and flu symptoms: • sinus pressure • minor body aches and pains • headache • nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) • fever

Dosage and administration

• do not take more than directed • the smallest effective dose should be used • swallow whole; do not crush or chew • drink a full glass of water with each dose • adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours • children under 12 years: do not use

Storage and handling

• each caplet contains: sodium 21 mg • FDA approved dissolution specification differs from the USP dissolution specification • store at 20-25°C (68-77°F) • store in a dry place

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

Pseudoephedrine HCl 120 mg, extended-release

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these cold, sinus, and flu symptoms:

  • sinus pressure
  • minor body aches and pains
  • headache
  • nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
  • fever

Warnings

WARNINGS SECTION

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

OTC - DO NOT USE SECTION

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • 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.
  • in children under 12 years of age

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • the stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug

When using this product

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • fever gets worse or lasts more than 3 days
  • you have difficulty swallowing or the caplet feels stuck in your throat
  • you get nervous, dizzy, or sleepless
  • nasal congestion lasts more than 7 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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 take more than directed
  • the smallest effective dose should be used
  • swallow whole; do not crush or chew
  • drink a full glass of water with each dose
  • adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: sodium 21 mg
  • FDA approved dissolution specification differs from the USP dissolution specification
  • store at 20-25°C (68-77°F)
  • store in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

Non-Drowsy

All Day Sinus & Cold-D

Naproxen Sodium, 220 mg

Pseudoephedrine Hydrochloride, 120 mg

Extended-Release Tablet

Pain Reliever/Fever Reducer (NSAID) | Nasal Decongestant

12-Hour Multi-Symptom Relief of:

Sinus Pressure, Headache, Sinus Congestion, Nasal Congestion & Body Aches

Actual Size

COMPARE TO ALEVE-D® SINUS & COLD active ingredients

1 Caplet – 12 Hours

100% Money Back Guarantee

20 CAPLETS**

**Capsule-Shaped Tablets

all-day-sinus-&-cold-d-front
all-day-sinus-&-cold-d-front
all-day-sinus-&-cold-d
all-day-sinus-&-cold-d

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1367426naproxen sodium 220 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN3
136742612 HR naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD3
1367426naproxen sodium 220 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NAPROXEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0605-1Leader All Day Sinus and Cold D20 in 1 CARTONTABLET, FILM COATED, EXTENDED RE203
70000-0605-1Leader All Day Sinus and Cold D1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0605LEADER ALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]3Current NDC, Legacy NDC, 2 package rows20250429_83f7cfbb-ab84-4594-ae7a-4a657385c8a7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0605-1EA - Each70000-0605bd517931-5953-49ba-a7ed-416d162b5b3512022-11-07

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-060570000-0605-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
NAPROXEN SODIUM9TN87S3A3CACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDENAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-17

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 22:38:342026-08A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-1784e616aacf4f…
2026-08-18 06:07:402026-07A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-03-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-03-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-03-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-03-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-03-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-03-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-03-173f01610625f2…
2019-09-15 20:21 UTC2019-09A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDEEQ 200MG BASE;120MGTABLET, EXTENDED RELEASE / ORAL2004-03-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDEEQ 200MG BASE;120MGTABLET, EXTENDED RELEASE / ORAL2004-03-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076518-001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE220MG;120MGTABLET, EXTENDED RELEASE / ORALRS2004-03-17f41ea6bd6efb…

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
Leader All Day Sinus and Cold DNAPROXEN SODIUM, PSEUDOEPHEDRINE HCLCardinal Health 110, LLC. dba Leader83f7cfbb-ab84-4594-ae7a-4a657385c8a72025-04-25WarningsExact identifier
ndc (package): 70000-0605-1
ndc (product): 70000-0605
ndc11 (package): 70000060501
spl id: 4d33af2f-53b6-49d2-927b-55d7f9273103
spl set id: 83f7cfbb-ab84-4594-ae7a-4a657385c8a7

Reported adverse events (FAERS/openFDA)#

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