Ibuprofen

Manufacturer: H.J. Harkins Company, Inc.
Effective date: 2012-02-08
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:30:57

Label at a glance#

ProductIbuprofen

Active ingredientIBUPROFEN

Label structure9 sections

Dosage and administration

do not take more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings) 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, children under 12 years: ask a doctor

Storage and handling

store between 20°-25°C (68°-77°F) avoid excessive heat 40°C (104°F) use by expiration date on package

Contacts and useful links#

PhoneLabel contact(800) 616-2471

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Use(s)

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:

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

Do not use

OTC - DO NOT USE SECTION

right before or after heart surgery
if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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, or kidney disease
you are taking a diuretic
you have 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
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
under a doctor"s care for any serious condition

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
have bloody or black stools
vomit blood
have stomach pain that does not get better
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.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
the smallest effective dose should be used
do not take longer than 10 days, unless directed by a doctor (see Warnings)
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,
children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store between 20°-25°C (68°-77°F)
avoid excessive heat 40°C (104°F)
use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

To Report Adverse Drug Event Call: (800) 616-2471

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

MAJOR®

NDC 0904-7915-80

†Compare to the active ingredient in Advil® Tablets

See New Warnings Information

Ibuprofen

Tablets

Ibuprofen Tablets, USP 200 mg

Pain Reliever

Fever Reducer (NSAID)

1000 COATED TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAD UNDER CAP IS BROKEN OR MISSING

50844 REV0910B29116

Distributed by

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA M-17 Rev.11/10

Re-order No. 700643

Repacked by:

H.J. Harkins Company, Inc.

Nipomo, CA 93444

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-187-00	2019-11-13	C162847	48780-1	97449f38-cca7-f6ea-e053-dbdaa90aa703	Rite Aid 44-329
52959-187-02	2019-11-13	C162847	48780-1	97449f38-cca7-f6ea-e053-dbdaa90aa703	Rite Aid 44-329
52959-187-03	2019-11-13	C162847	48780-1	97449f38-cca7-f6ea-e053-dbdaa90aa703	Rite Aid 44-329
52959-187-10	2019-11-13	C162847	48780-1	97449f38-cca7-f6ea-e053-dbdaa90aa703	Rite Aid 44-329
52959-187-15	2019-11-13	C162847	48780-1	97449f38-cca7-f6ea-e053-dbdaa90aa703	Rite Aid 44-329
52959-187-20	2019-11-13	C162847	48780-1	97449f38-cca7-f6ea-e053-dbdaa90aa703	Rite Aid 44-329
52959-187-21	2019-11-13	C162847	48780-1	97449f38-cca7-f6ea-e053-dbdaa90aa703	Rite Aid 44-329
52959-187-24	2019-11-13	C162847	48780-1	97449f38-cca7-f6ea-e053-dbdaa90aa703	Rite Aid 44-329
52959-187-25	2019-11-13	C162847	48780-1	97449f38-cca7-f6ea-e053-dbdaa90aa703	Rite Aid 44-329
52959-187-30	2019-11-13	C162847	48780-1	97449f38-cca7-f6ea-e053-dbdaa90aa703	Rite Aid 44-329
52959-187-40	2019-11-13	C162847	48780-1	97449f38-cca7-f6ea-e053-dbdaa90aa703	Rite Aid 44-329
52959-187-50	2019-11-13	C162847	48780-1	97449f38-cca7-f6ea-e053-dbdaa90aa703	Rite Aid 44-329
52959-187-60	2019-11-13	C162847	48780-1	97449f38-cca7-f6ea-e053-dbdaa90aa703	Rite Aid 44-329
52959-187-90	2019-11-13	C162847	48780-1	97449f38-cca7-f6ea-e053-dbdaa90aa703	Rite Aid 44-329

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-187-00	Ibuprofen	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	1
52959-187-02	Ibuprofen	120 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	120	1
52959-187-03	Ibuprofen	200 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	200	1
52959-187-10	Ibuprofen	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10	1
52959-187-15	Ibuprofen	15 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	15	1
52959-187-20	Ibuprofen	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	1
52959-187-21	Ibuprofen	21 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	21	1
52959-187-24	Ibuprofen	24 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	24	1
52959-187-25	Ibuprofen	25 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	25	1
52959-187-30	Ibuprofen	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	1
52959-187-40	Ibuprofen	40 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	40	1
52959-187-50	Ibuprofen	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	1
52959-187-60	Ibuprofen	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	1
52959-187-90	Ibuprofen	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-187	IBUPROFEN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 14 package rows	20120215_ec219fae-1b21-405f-939d-992b7ccc38c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-187-00	EA - Each	52959-187	18ed400c-331c-4321-a8a7-bd159c913ae2	1	2012-07-24
52959-187-02	EA - Each	52959-187	478246e7-d4f8-44a5-9204-badd9b418a4f	1	2012-07-24
52959-187-03	EA - Each	52959-187	be4b21df-adef-4e7b-96b6-7e2c4c3c06b7	1	2012-07-24
52959-187-10	EA - Each	52959-187	a7ac0fd1-56c8-45d6-b34e-20e2b2719222	1	2012-07-24
52959-187-15	EA - Each	52959-187	f2952537-e889-4e0d-8abf-22b54cec2883	1	2012-07-24
52959-187-20	EA - Each	52959-187	b1ef9206-5fbf-4075-9948-d2c89c26b5ad	1	2012-07-24
52959-187-21	EA - Each	52959-187	89e5a2e2-6942-45bf-96a0-479bb7da4125	1	2012-07-24
52959-187-24	EA - Each	52959-187	8c858ed3-336b-4df6-871c-5940a75fdd29	1	2012-07-24
52959-187-25	EA - Each	52959-187	3481ff8e-55cf-490a-93fd-20e677f0f6a3	1	2012-07-24
52959-187-30	EA - Each	52959-187	79c925ef-5f61-4916-971a-2e449b3ad1ea	1	2012-07-24
52959-187-40	EA - Each	52959-187	5f044e53-3f2f-4f89-b41a-a9b654fc1c1c	1	2012-07-24
52959-187-50	EA - Each	52959-187	db1b32d8-7ddb-4226-8ab6-01fbb30bfdd0	1	2012-07-24
52959-187-60	EA - Each	52959-187	64c12be9-eff4-4097-a5e8-4a40c47ae0d6	1	2012-07-24
52959-187-90	EA - Each	52959-187	614f5dea-44b7-411b-8983-99f935a31c96	1	2012-07-24
0904-7915-24	EA - Each	0904-7915	0ebdac4b-1423-4631-bd60-3aa7a7196170	1	2013-02-13
0904-7915-40	EA - Each	0904-7915	c84dc8bb-62dd-4b45-a91f-796d05fd6027	1	2013-02-13
0904-7915-51	EA - Each	0904-7915	3fe69536-1766-4963-acb3-21a888386688	1	2013-02-13
0904-7915-59	EA - Each	0904-7915	e3a622d9-4151-4d28-bb86-3432d0d0809f	1	2013-02-13
0904-7915-70	EA - Each	0904-7915	c84e7340-52bf-4996-9009-03bc868e8be9	1	2013-02-13
0904-7915-80	EA - Each	0904-7915	09add50d-10b5-4ab8-97f7-db45326bb4e9	1	2013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Ibuprofen
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52959-187	52959-187-00, 52959-187-02, 52959-187-03, 52959-187-10, 52959-187-15, 52959-187-20, 52959-187-21, 52959-187-24, 52959-187-25, 52959-187-30, 52959-187-40, 52959-187-50, 52959-187-60, 52959-187-90
0904-7915

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE	J2B2A4N98G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
POLYETHYLENE GLYCOL	3WJQ0SDW1A	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 159 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE / ORAL		1488 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	PELLET / ORAL		1140 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 27 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAMUSCULAR	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SYSTEM / TOPICAL		54 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	221 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / RECTAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / ORAL		305 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	193.8 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	FILM, EXTENDED RELEASE / TRANSDERMAL	675 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates

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
6608c82e-6913-4928-b4fb-3815863ce2d0			ec219fae-1b21-405f-939d-992b7ccc38c1	2012-02-08	Warnings	Exact identifier spl id: 6608c82e-6913-4928-b4fb-3815863ce2d0 spl set id: ec219fae-1b21-405f-939d-992b7ccc38c1

Reported adverse events (FAERS/openFDA)#

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