ADVIL- ibuprofen tablet, coated

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2023-12-05
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:19:12

Label at a glance#

ProductADVIL
Active ingredientIBUPROFEN
Label structure14 sections

Indications and uses

•temporarily relieves minor aches and pains due to: •headache •toothache •backache •menstrual cramps •the common cold •muscular aches •minor pain of arthritis •temporarily reduces fever

Dosage and administration

•do not take more than directed •the smallest effective dose should be used •adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist •if pain or fever does not respond to 1 tablet, 2 tablets may be used •do not exceed 6 tablets in 24 hours, unless directed by a doctor •children under 12 years: ask a doctor

Storage and handling

•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)

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (NSAID) *

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Uses

INDICATIONS & USAGE SECTION

•temporarily relieves minor aches and pains due to:

•headache
•toothache
•backache
•menstrual cramps
•the common cold
•muscular aches
•minor pain of arthritis

•temporarily reduces fever

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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

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 non-prescription 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 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

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, 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 aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug

When using this product

• 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 10 days
•fever gets worse or lasts more than 3 days
•redness or swelling is present in the painful area
•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 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.

Directions

DOSAGE & ADMINISTRATION SECTION

•do not take more than directed
•the smallest effective dose should be used
•adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
•if pain or fever does not respond to 1 tablet, 2 tablets may be used
•do not exceed 6 tablets in 24 hours, unless directed by a doctor
•children under 12 years: ask a doctor

Other Information

STORAGE AND HANDLING 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

acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-800-88-ADVIL

SPL UNCLASSIFIED SECTION

Repackaged and distributed with permission of GSK Consumer Healthcare by:
Convenience Valet®, Glendale Heights, IL 60139

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil

Ibuprofen Tablets, 200mg

Pain Reliever/Fever Reducer (NSAID)

2 Packets of

2 Coated Tablets Each

Advil

Tablets

Advil 4ctAdvil 4ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil

Ibuprofen Tablets, 200mg

Pain Reliever/Fever Reducer (NSAID)

3 Packets of

2 Coated Tablets Each

Advil

Tablets

Advil 6ctAdvil 6ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil

Ibuprofen Tablets, 200mg

Pain Reliever/Fever Reducer (NSAID)

  • Headache
  • Minor Pain of Arthritis
  • Toothache
  • Muscular Aches
  • Menstrual Cramps
  • Fever

30 PACKETS OF 2 COATED TABLETS EACH

Advil 30ctAdvil 30ct

CVP 4 Count Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil

Ibuprofen Tablets, 200mg

Pain Reliever/Fever Reducer (NSAID)

[pill image]

Tablets

4

Coated

Tablets

CVP

HEALTH

Advil CVP 4ctAdvil CVP 4ct

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-1005ADVIL (IBUPROFEN TABLET COATED) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]9Legacy NDC20231207_d09ddb5a-465b-519f-e053-2995a90a16d5.zip
29485-6500ADVIL (IBUPROFEN TABLET COATED) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]9Legacy NDC20231207_d09ddb5a-465b-519f-e053-2995a90a16d5.zip
29485-6749ADVIL (IBUPROFEN TABLET COATED) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]9Legacy NDC20231207_d09ddb5a-465b-519f-e053-2995a90a16d5.zip
29485-7012ADVIL (IBUPROFEN TABLET COATED) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]9Legacy NDC20231207_d09ddb5a-465b-519f-e053-2995a90a16d5.zip

Products#

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DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 68 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
N018989-001ADVILIBUPROFEN200MGTABLET / ORALRLD, RS1984-05-18

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 22:38:342026-08N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-1884e616aacf4f…
2026-08-18 06:07:402026-07N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018989-001ADVIL200MGTABLET / ORAL1984-05-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018989-001ADVIL200MGTABLET / ORAL1984-05-183f01610625f2…
2019-09-15 20:21 UTC2019-09N018989-001ADVIL200MGTABLET / ORAL1984-05-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N018989-001ADVIL200MGTABLET / ORAL1984-05-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018989-001ADVIL200MGTABLET / ORALRLD, RS1984-05-18f41ea6bd6efb…

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0bc929a5-ed16-f40d-e063-6294a90a8294d09ddb5a-465b-519f-e053-2995a90a16d52023-12-05WarningsExact identifier
spl id: 0bc929a5-ed16-f40d-e063-6294a90a8294
spl set id: d09ddb5a-465b-519f-e053-2995a90a16d5

Reported adverse events (FAERS/openFDA)#

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