Vicks Sinex D

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2020-05-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:29:57

Label at a glance#

ProductVicks Sinex D Severe Sinus and Cold
Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM
Label structure10 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 store at 20-25°C (68 -77°F) store in a dry place

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

Purpose

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:

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke.These can be fatal.The risk is higher if you usemore 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 you

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 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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
  • 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

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 30 Caplet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VICKS ®

Sinex ™ D

SEVERE

Sinus & COLD

Naproxen sodium 220 mg and Pseudoephedrine hydrochloride 120 mg extended-release tablet
Pain Reliever/Fever Reducer (NSAID) and Nasal Decongestant

12 HOUR

MULTI-SYMPTOM RELIEF OF:
Sinus Pressure, Headache,
Sinus Congestion,
Nasal Congestion & Body Aches

See New Warnings

1 caplet-12 hours

Non-Drowsy

**Capsule-Shaped Tablets

30 CAPLETS

921921

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-921VICKS SINEX D SEVERE SINUS AND COLD (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2Legacy NDC20200520_7d3ee6a9-e482-af6a-e053-2a91aa0a64d6.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-92137000-921-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
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
4570dcaf-95c0-124a-e063-6294a90ab93e7d3ee6a9-e482-af6a-e053-2a91aa0a64d62025-12-08WarningsExact identifier
spl set id: 7d3ee6a9-e482-af6a-e053-2a91aa0a64d6

Reported adverse events (FAERS/openFDA)#

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