FDA.reportPublic FDA data

Motrin IB, TRAVEL BASIX

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:21:41

Label at a glance#

ProductMotrin IB
Active ingredientIBUPROFEN
Label structure13 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps 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 older take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets 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 store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F) do not use if pouch is torn or damaged

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (NSAID) 1

1 nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • backache
    • the common cold
    • menstrual cramps
  • 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 chances are 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 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 ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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, or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks later or in 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
adults and children 12 years and older
  • take 1 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • read all warnings and directions before use
  • store at 20-25°C (68-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • do not use if pouch is torn or damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com

SPL UNCLASSIFIED SECTION

Distributed by: JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Healthcare Division

Fort Washington, PA 19034 USA ©J&JCI 2022 www.motrin.com

Repackaged and distributed by: Lil' Drug Store Products, Inc.
9300 Earhart Lane SW, Cedar Rapids, IA 52404

1-877-507-6516 (M-F 8AM-4:30PM CST) www.lildrugstore.com 97122C-US-08-22

PRINCIPAL DISPLAY PANEL - 200 mg Tablet Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See Revised Warnings

Motrin ® IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

[caplet image]

4 Coated Caplets** 2 POUCHES OF 2 CAPLETS EACH

**Capsule-Shaped Tablets

[Lil' Drug Store® logo]

PDP/PackagePDP/Package

Motrin IB 6ct TRAVEL BASIX - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Motrin ® IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer (NSAID)

[caplets image]

6

Coated Caplets**

3POUCHES OF 2 CAPLETS EACH

**Capsule-Shaped Tablets

[TRAVEL BASIX logo]

PDP/PackagePDP/Package

Motrin IB 4ct CVP HEALTH - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEE REVISED WARNING

Motrin ® IB

Ibuprofen Tablets USP, 200 mg

Pain Reliever/Fever Reducer(NSAID)

[caplets image]

4

Coated Caplets**

2POUCHES OF 2 CAPLETS EACH

**Capsule-Shaped Tablets

[CVP HEALTH logo]

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN9
201126Motrin IB 200 MG Oral TabletPSN9
201126ibuprofen 200 MG Oral Tablet [Motrin]SBD9
310965ibuprofen 200 MG Oral TabletSCD9
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY9
201126Motrin 200 MG Oral TabletSY9

DailyMed Pharmacologic Classes#

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

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
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6412-3Motrin IB, TRAVEL BASIX3 in 1 CARTONTABLET, FILM COATED39
66715-6412-3Motrin IB, TRAVEL BASIX2 in 1 POUCHTABLET, FILM COATED29
66715-6512-2Motrin IB, CVP HEALTH2 in 1 CARTONTABLET, FILM COATED29
66715-6512-2Motrin IB, CVP HEALTH2 in 1 POUCHTABLET, FILM COATED29
66715-9812-1Motrin IB1 in 1 CARTONTABLET, FILM COATED19
66715-9812-1Motrin IB2 in 1 POUCHTABLET, FILM COATED29
66715-9812-2Motrin IB2 in 1 POUCHTABLET, FILM COATED29
66715-9812-2Motrin IB2 in 1 CARTONTABLET, FILM COATED29
66715-9812-3Motrin IB3 in 1 CARTONTABLET, FILM COATED39
66715-9812-3Motrin IB2 in 1 POUCHTABLET, FILM COATED29
66715-9812-7Motrin IB2 in 1 POUCHTABLET, FILM COATED29
66715-9812-7Motrin IB30 in 1 BOX, UNIT-DOSETABLET, FILM COATED309
66715-9812-8Motrin IB30 in 1 BOX, UNIT-DOSETABLET, FILM COATED309
66715-9812-8Motrin IB2 in 1 POUCHTABLET, FILM COATED29

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
66715-981266715-9812-1, 66715-9812-2, 66715-9812-7, 66715-9812-3, 66715-9812-8
66715-651266715-6512-2
66715-641266715-6412-3

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C RED NO. 40WZB9127XOAIACT
ALUMINUM OXIDELMI26O6933IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FERRIC OXIDE RED1K09F3G675IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
IBUPROFENWK2XYI10QMACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C RED NO. 40WZB9127XOAIACT
ALUMINUM OXIDELMI26O6933IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FERRIC OXIDE RED1K09F3G675IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
IBUPROFENWK2XYI10QMACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C RED NO. 40WZB9127XOAIACT
ALUMINUM OXIDELMI26O6933IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FERRIC OXIDE RED1K09F3G675IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT

Source Document#

Source XML · Source PDF

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 44.

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
A077349-001IBUPROFENIBUPROFEN200MGTABLET / ORALRS2005-06-21

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21c2088c7a36db…
2026-09-14 22:38:342026-08A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2184e616aacf4f…
2026-08-18 06:07:402026-07A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-213f01610625f2…
2019-09-15 20:21 UTC2019-09A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077349-001IBUPROFEN200MGTABLET / ORALRS2005-06-213a93d1ddd44b…

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
Motrin IB, TRAVEL BASIXIBUPROFENLil' Drug Store Products, Inc.c2b99756-3e03-4d9f-9ce6-7db879afe3a12025-12-10WarningsExact identifier
ndc (package): 66715-9812-2
ndc (package): 66715-6512-2
ndc (package): 66715-9812-8
ndc (package): 66715-9812-3
ndc (package): 66715-6412-3
ndc (package): 66715-9812-1
ndc (package): 66715-9812-7
ndc (product): 66715-6412
ndc (product): 66715-9812
ndc (product): 66715-6512
ndc11 (package): 66715981201
ndc11 (package): 66715981207
ndc11 (package): 66715981202
ndc11 (package): 66715651202
ndc11 (package): 66715981203
ndc11 (package): 66715981208
ndc11 (package): 66715641203
spl id: 459bde25-f542-9aa4-e063-6394a90a6cb1
spl set id: c2b99756-3e03-4d9f-9ce6-7db879afe3a1

Reported adverse events (FAERS/openFDA)#

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