Ibuprofen Softgels

Manufacturer: Breeden Brothers, LLC
Effective date: 2018-01-01
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:56:55

Label at a glance#

ProductIbuprofen Softgels

Active ingredientIBUPROFEN

Label structure12 sections

Indications and uses

_ temporarily relieves minor aches and pains due to: _ muscular aches _ the common cold _ headache _ toothache _ backache _ menstrual cramps _ 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 capsule every 4 to 6 hours while symptoms persist _ if pain or fever does not respond to 1 capsule, 2 capsules may be used _ do not exceed 6 capsules in 24 hours, unless directed by a doctor _ children under 12 years: ask a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-901-2420

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Solubilized ibuprofen equal to Pain reliever/ 200 mg ibuprofen (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

fever reducer (present as the free acid and potassium salt)

Drug Facts (continued)

Uses

INDICATIONS & USAGE SECTION

_ temporarily relieves minor aches and pains due to:

_ muscular aches

_ the common cold

_ headache

_ toothache

_ backache

_ menstrual cramps

_ minor pain of arthritis

_ temporarily reduces fever

Warnings

WARNINGS SECTION

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

_ blisters

_ rash

_ hives

_ asthma (wheezing)

_ shock

_ skin reddening

_ facial swelling

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:

_ take a blood thinning (anticoagulant) or

Drug Facts (continued)

steroid drug

_ are age 60 or older

_ have had stomach ulcers or bleeding problems

_ 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

_ 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 a history of stomach problems, such as heartburn

_ you are taking a diuretic

Drug Facts (continued)

_ you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma

_ 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

_ taking any other drug

_ under a doctor's care for any serious condition

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

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

_ you experience any of the following signs of

Drug Facts (continued)

stomach bleeding:

_ feel faint

_ have stomach pain that does not get better

_ have bloody or black stools

_ vomit blood

_ 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 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)

Drug Facts (continued)

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 capsule every 4 to 6 hours while symptoms persist

_ if pain or fever does not respond to 1 capsule, 2 capsules may be used

_ do not exceed 6 capsules in 24 hours, unless directed by a doctor

_ children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

_ each capsule contains: potassium 28 mg

_ read all warnings and directions before use.

_ store at 20°-25°C (68°-77°F)

_ avoid excessive heat above 40°C (104°F)

Drug Facts (continued)

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C green #3, gelatin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, potassium hydroxide, purified water, sorbitol special, and white edible ink

Questions or comments?

OTC - QUESTIONS SECTION

1-800-901-2420

Product of China

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

b+b
better by giving
IBUPROFEN
SOFTGELS
20 Softgels
(200 mg each)

PRINCIPAL DISPLAY PANEL b+b better by giving IBUPROFEN SOFTGELS 20 Softgels (200 mg each)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

b+b
better by giving
IBUPROFEN
SOFTGELS
40 Softgels
(200 mg each)

PRINCIPAL DISPLAY PANEL b+b better by giving IBUPROFEN SOFTGELS 40 Softgels (200 mg each)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70729-509-32
b+b
IBUPROFEN
SOFTGELS
120 Softgels
(200 mg each)

PRINCIPAL DISPLAY PANEL NDC 70729-509-32 b+b IBUPROFEN SOFTGELS 120 Softgels (200 mg each)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310964	ibuprofen 200 MG Oral Capsule	PSN	2
310964	ibuprofen 200 MG Oral Capsule	SCD	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
IBUPROFEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70729-000-01	2020-01-31	C162847	48780-1	9d75b9d0-0bbf-f424-e053-dadaa90a57ce	Ibuprofen Softgels
70729-000-02	2020-01-31	C162847	48780-1	9d75b9d0-0bbf-f424-e053-dadaa90a57ce	Ibuprofen Softgels
70729-509-32	2020-01-31	C162847	48780-1	9d75b9d0-0bbf-f424-e053-dadaa90a57ce	Ibuprofen Softgels

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70729-000-01	Ibuprofen Softgels	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	2
70729-000-02	Ibuprofen Softgels	40 in 1 BOTTLE, PLASTIC	CAPSULE	40	2
70729-509-32	Ibuprofen Softgels	120 in 1 BOTTLE, PLASTIC	CAPSULE	120	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70729-000	IBUPROFEN SOFTGELS (IBUPROFEN) CAPSULE [BREEDEN BROTHERS, LLC]	2	Legacy NDC, 2 package rows	20180929_1fa232d5-1997-49b2-bf4f-361652e50a6e.zip
70729-509	IBUPROFEN SOFTGELS (IBUPROFEN) CAPSULE [BREEDEN BROTHERS, LLC]	2	Legacy NDC, 1 package rows	20180929_1fa232d5-1997-49b2-bf4f-361652e50a6e.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Ibuprofen Softgels
ibuprofen
FD&C GREEN NO. 3
GELATIN
ISOPROPYL ALCOHOL
MEDIUM-CHAIN TRIGLYCERIDES
POLYETHYLENE GLYCOLS
POTASSIUM HYDROXIDE
WATER
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70729-000	70729-000-01, 70729-000-02
70729-509	70729-509-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
GELATIN	2G86QN327L	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
GELATIN	2G86QN327L	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206568-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2016-06-21

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206568-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2016-06-21	`f41ea6bd6efb…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
1658e69c-3b21-4829-b2fc-1234e7ff37f4			1fa232d5-1997-49b2-bf4f-361652e50a6e	2018-01-01	Warnings	Exact identifier spl id: 1658e69c-3b21-4829-b2fc-1234e7ff37f4 spl set id: 1fa232d5-1997-49b2-bf4f-361652e50a6e

Reported adverse events (FAERS/openFDA)#

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