Congestion Relief

Manufacturer
H E B
Effective date
2019-12-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:01:46

Label at a glance#

ProductCongestion Relief
Active ingredientIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

• temporarily relieves these symptoms associated with the common cold or flu: • headache • fever • sinus pressure • nasal congestion • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose

Dosage and administration

• do not take more than directed • adults and children 12 years of age and over: • take 1 tablet every 4 hours while symptoms persist. • do not use more than 6 tablets in any 24-hour period unless directed by a doctor • children under 12 years of age: do not use because this product contains too much medication for children under this age

Storage and handling

• store at 20-25°C (68-77°). Avoid excessive heat above 40°C (104°F). • read all warnings and directions before use. Keep carton.

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms associated with the common cold or flu:
  • headache
  • fever
  • sinus pressure
  • nasal congestion
  • minor body aches and pains
  • reduces swelling of the nasal passages
  • temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Allergy alert: Ibuprofen 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

  • in children under 12 years of age because this product contains too much medication for children under this age
  • 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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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

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 product that contains phenylephrine or any other nasal decongestant
  • taking aspirin for heart attack or stroke, because ibuprofen 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
  • pain gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • nasal congestion lasts for more than 7 days
  • symptoms continue or get worse
  • redness or swelling is present in the painful area
  • you get nervous, dizzy, or sleepless
  • any new symptoms appear

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use ibuprofen 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.

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
  • adults and children 12 years of age and over:
  • take 1 tablet every 4 hours while symptoms persist.
  • do not use more than 6 tablets in any 24-hour period unless directed by a doctor
  • children under 12 years of age: do not use because this product contains too much medication for children under this age

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°). Avoid excessive heat above 40°C (104°F).
  • read all warnings and directions before use. Keep carton.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Advil® Sinus Congestion & Pain active ingredients

See New Warnings

Congestion Relief

Ibuprofen 200 mg

Phenylephrine Hydrochloride 10 mg Tablets

Pain Reliever/Fever Reducer (NSAID) & Nasal Decongestant

Sinus Congestion & Pain

NON-DROWSY

Relief of:

Nasal Congestion

Headache

Sinus Pressure

Fever

Nasal Swelling

Body Aches

actual size

20 COATED TABLETS

One Tablet Dose!

1581J-congestion-relief.jpg
1581J-congestion-relief.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1369775ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSN3
1369775ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-158-60Congestion Relief1 in 1 BLISTER PACKTABLET, FILM COATED13
37808-158-60Congestion Relief20 in 1 CARTONTABLET, FILM COATED203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-158CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [H E B]3Legacy NDC, 2 package rows20191206_8e46fe47-e429-4b0c-ae4a-9b8e5e6a5036.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-15837808-158-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDEIBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03

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 22:38:342026-08A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-0384e616aacf4f…
2026-08-18 06:07:402026-07A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-0387673890dc5c…
2021-03-12 10:30 UTC2021-03A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-033f01610625f2…
2019-09-15 20:21 UTC2019-09A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03b00525d2431f…
2019-07-19 19:46 UTC2019-07A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03053a50430f4f…
2023-01-26 05:58 UTC2023-01A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203200-001IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORAL2014-07-03f41ea6bd6efb…

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
37000525-0596-453b-8732-152d7e6591898e46fe47-e429-4b0c-ae4a-9b8e5e6a50362026-06-30WarningsExact identifier
spl set id: 8e46fe47-e429-4b0c-ae4a-9b8e5e6a5036

Reported adverse events (FAERS/openFDA)#

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