Advil Allergy and Congestion Relief

Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2023-03-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:54:30

Label at a glance#

ProductAdvil Allergy and Congestion Relief
Active ingredientCHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

• temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: • runny nose • itchy, watery eyes • itching of the nose or throat • sneezing • nasal congestion • sinus pressure • headache • fever • 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

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine Maleate 4 mg

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Antihistamine

Pain reliever/Fever reducer

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
• runny nose • itchy, watery eyes • itching of the nose or throat
• sneezing • nasal congestion • sinus pressure
• headache • fever • 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

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

• you have a breathing problem such as emphysema or chronic bronchitis
• 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, glaucoma or have trouble urinating due to an enlarged prostate gland • 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 sedatives or tranquilizers
• taking any other product that contains phenylephrine, chlorpheniramine or any other nasal decongestant or antihistamine
• 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
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed • avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• may cause excitability especially in children

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
• 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 • redness or swelling is present in the painful area • you get nervous, dizzy, or sleepless • symptoms continue or get worse
• 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.

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

SPL UNCLASSIFIED SECTION

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

​Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, artificial flavors, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, glyceryl behenate, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, silicon dioxide, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil AllergyAdvil Allergy

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1310503chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSN4
1310503chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-149-01Advil Allergy and Congestion Relief1 in 1 CARTONTABLET, COATED14
67751-149-01Advil Allergy and Congestion Relief1 in 1 POUCHTABLET, COATED14
67751-149-02Advil Allergy and Congestion Relief2 in 1 CARTONTABLET, COATED24
67751-149-02Advil Allergy and Congestion Relief1 in 1 POUCHTABLET, COATED14
67751-149-03Advil Allergy and Congestion Relief12 in 1 TRAYTABLET, COATED124
67751-149-03Advil Allergy and Congestion Relief1 in 1 POUCHTABLET, COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-149ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [NAVAJO MANUFACTURING COMPANY INC.]4Current NDC, Legacy NDC, 6 package rows20230316_d40bf078-ee6f-4c64-9c74-e4e770c150bf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0196-01EA - Each0573-01969d14018e-d877-4eef-85c7-31c9376c8d9812016-05-16
0573-0196-10EA - Each0573-0196fd9744d0-f04f-434a-804a-bda9e470cfe012013-02-13
0573-0196-20EA - Each0573-0196cc6b0675-9eef-4bbb-b743-6c202410d3f012016-05-16

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67751-14967751-149-01, 67751-149-02, 67751-149-03
0573-0196

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022113-001ADVIL ALLERGY AND CONGESTION RELIEFCHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21
N022113-002ADVIL MULTI-SYMPTOM COLD & FLUCHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-2184e616aacf4f…
2026-09-14 22:38:342026-08N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-2884e616aacf4f…
2026-08-18 06:07:402026-07N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022113-001ADVIL ALLERGY AND CONGESTION RELIEF4MG;200MG;10MGTABLET / ORALRLD, RS2011-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022113-002ADVIL MULTI-SYMPTOM COLD & FLU4MG;200MG;10MGTABLET / ORALRLD, RS2017-04-2874a2ff9319b5…

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
Advil Allergy and Congestion ReliefCHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa6cc97d8-252a-4527-a470-6d9e356342fd2025-04-09WarningsExact identifier
ndc (product): 0573-0196
Advil Allergy and Congestion ReliefCHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.d40bf078-ee6f-4c64-9c74-e4e770c150bf2023-03-15WarningsExact identifier
ndc (package): 67751-149-01
ndc (package): 67751-149-02
ndc (package): 67751-149-03
ndc (product): 67751-149
ndc11 (package): 67751014903
ndc11 (package): 67751014901
ndc11 (package): 67751014902
spl id: f6f71bb0-5bac-59f7-e053-6394a90abf8e
spl set id: d40bf078-ee6f-4c64-9c74-e4e770c150bf

Reported adverse events (FAERS/openFDA)#

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