Ibuprofen

Manufacturer: Pharbest Pharmaceuticals, Inc.
Effective date: 2018-05-19
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:55:37

Label at a glance#

ProductIbuprofen

Active ingredientIBUPROFEN

Label structure16 sections

Indications and uses

temporarily relieves minor aches and pain 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 older take 1 tablet every4 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 consult a doctor

Storage and handling

Tamper Evident: do not use if safety seal under cap is broken or missing store at room temperature (20 o - 25 o C) avoid excessive heat above 40 o C (104 o F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

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 pain due to:

headache
toothache
backache
menstrual cramps
the common cold
muscular aches
minor pain of arthritis
temporarily reduces fever

Warnings

WARNINGS SECTION

Allergy alert:

WARNINGS AND PRECAUTIONS 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:

WARNINGS AND PRECAUTIONS 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 everyday 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 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 or asthma
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
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 stomach bleeding:
feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better
pain gets worse or last for more than 10 days
fever gets worse or last 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). This Package for Households Without Young Children.

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 tablet every4 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	consult a doctor

Other information

STORAGE AND HANDLING SECTION

Tamper Evident: do not use if safety seal under cap is broken or missing
store at room temperature (20^o- 25^oC)
avoid excessive heat above 40^oC (104^oF)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, red iron oxide, talc & titanium dioxide

Questions? Adverse drug event call: (866)562-2756 Mon-Fri: 8 AM to 4 PM

OTC - QUESTIONS SECTION

*This product is not manufactured or distributed by Pfizer Consumer Products, owner of the registered trademark ADVIL^®.

Manufactured for:

Pharbest Pharmaceuticals, Inc.,

Farmingdale, NY 11735

LRev 02/16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 16103-0396-11

PHARBEST

*Compare to the active ingredient in Advil®

Pain Reliever / Fever Reducer (NSAID)

IBUPROFEN

Tablets

200mg

1000 Tablets

Pharbest Ibuprofen 200 mg Brown Tablet Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310965	ibuprofen 200 MG Oral Tablet	PSN	1
310965	ibuprofen 200 MG Oral Tablet	SCD	1
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	1

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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16103-396-04	2022-01-28	C162847	48780-1	d6a99b39-4ed2-a426-e053-dadaa90af4c2	Drug Facts
16103-396-06	2022-01-28	C162847	48780-1	d6a99b39-4ed2-a426-e053-dadaa90af4c2	Drug Facts
16103-396-08	2022-01-28	C162847	48780-1	d6a99b39-4ed2-a426-e053-dadaa90af4c2	Drug Facts
16103-396-11	2022-01-28	C162847	48780-1	d6a99b39-4ed2-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16103-396-04	Ibuprofen	1 in 1 CARTON	TABLET	1	1
16103-396-04	Ibuprofen	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
16103-396-06	Ibuprofen	1 in 1 CARTON	TABLET	1	1
16103-396-06	Ibuprofen	50 in 1 BOTTLE, PLASTIC	TABLET	50	1
16103-396-08	Ibuprofen	1 in 1 CARTON	TABLET	1	1
16103-396-08	Ibuprofen	100 in 1 BOTTLE, PLASTIC	TABLET	100	1
16103-396-11	Ibuprofen	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16103-396	IBUPROFEN TABLET [PHARBEST PHARMACEUTICALS, INC.]	1	Legacy NDC, 7 package rows	20180520_5ebcd4d3-0397-4061-be0f-7e50b9d1780d.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Ibuprofen
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, CORN
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
16103-396	16103-396-11, 16103-396-08, 16103-396-06, 16103-396-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL 3350	G2M7P15E5P	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
STARCH, CORN	O8232NY3SJ	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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
A091239-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-02-01

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	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091239-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-01	`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
b930519b-3c6f-4f19-8e84-227c44b06331			5ebcd4d3-0397-4061-be0f-7e50b9d1780d	2018-05-19	Warnings	Exact identifier spl id: b930519b-3c6f-4f19-8e84-227c44b06331 spl set id: 5ebcd4d3-0397-4061-be0f-7e50b9d1780d

Reported adverse events (FAERS/openFDA)#

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