Drug Facts

Manufacturer: HEB | Bionpharma Inc. | Patheon Softgels Inc. | ESJAY PHARMA PRIVATE LIMITED
Effective date: 2026-06-23
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: monthly-update
Hydrated at: 2026-07-17 21:35:21

Label at a glance#

ProductIbuprofen

Active ingredientIBUPROFEN

Label structure11 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 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

Storage and handling

each capsule contains: potassium 20 mg read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F). Protect from light.

Contacts and useful links#

PhoneLabel contact1-888-235-2466

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
*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: 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

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

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

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 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

STORAGE AND HANDLING SECTION

each capsule contains: potassium 20 mg
read all warnings and directions before use. Keep carton.
store at 20° to 25°C (68° to 77°F)
avoid excessive heat above 40°C (104°F). Protect from light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

For India Manufacturing Site:

FD&C Blue #1, gelatin, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-888-235-2466

SPL UNCLASSIFIED SECTION

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION.

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “ SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.

This product is not manufactured or distributed by the owners of Advil ^®LIQUI-GELS ^®.

MADE WITH PRIDE AND CARE FOR
H-E-B®, SAN ANTONIO, TX 78204

H-E-B

100 %

GUARANTEE

promise

If you aren't completely pleased

with this product, we'll be happy

replace it or refund your money

You have our word on it.

L0000622

R0522

For India Manufacturing Site:
Code: TN/DRUGS/TN/25/00074

Product

of India

P3384/00/25
L0000990
R0225

20's count Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to

Advil ^®LIQUI-GELS ^®active ingredient ^†

NDC 37808-609-11

H-E-B _®

Ibuprofen

Capsules, 200 mg

Pain Reliever/Fever Reducer

(NSAID)

mini

capsule

Smaller

Capsule

Same

Strength

actual

size

20 SOFTGELS*

(*Liquid Filled Capsules)

carton

300's label-MADE IN INDIA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to

Advil ®LIQUI-GELS ®active ingredient †

NDC 37808-609-83

H-E-B ®

Ibuprofen

Capsules, 200 mg

Pain Reliever/Fever Reducer

(NSAID)

mini

capsule

Smaller

Capsule

Same

Strength

actual

size

300 SOFTGELS*

(*Liquid Filled Capsules)

300s-front

300s-back

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
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
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Ibuprofen
FD&C BLUE NO. 1
GELATIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POTASSIUM HYDROXIDE
WATER
SORBITAN
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37808-609	37808-609-11, 37808-609-83, 37808-609-78

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
WATER	059QF0KO0R	IACT
SORBITAN	6O92ICV9RU	IACT
SORBITOL	506T60A25R	IACT
IBUPROFEN	WK2XYI10QM	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
5	2025-08-07	full-release	2026-06-01 01:09:43

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
A078682-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2009-03-24

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	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078682-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-03-24	`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
Ibuprofen	IBUPROFEN	HEB	ca4be24c-5d92-ddc9-e053-2a95a90aa5a7	2026-06-23	Warnings	Exact identifier ndc (package): 37808-609-11 ndc (package): 37808-609-83 ndc (package): 37808-609-78 ndc (product): 37808-609 ndc11 (package): 37808060983 ndc11 (package): 37808060978 ndc11 (package): 37808060911 spl id: 54eed0cd-0d76-2c00-e063-6294a90a6701 spl set id: ca4be24c-5d92-ddc9-e053-2a95a90aa5a7

Reported adverse events (FAERS/openFDA)#

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