IBUPROFEN tablet, coated

IBUPROFEN by

Drug Labeling and Warnings

IBUPROFEN by is a Otc medication manufactured, distributed, or labeled by TARGET CORPORATION, TIME CAP LABORATORIES INC, MARKSANS PHARMA LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ibuprofen 200 mg (NSAID)*

* nonsteroidal anti-inflammatory drug

INACTIVE INGREDIENT

Silicon dioxide, croscarmellose sodium, FD & C yellow # 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.

PURPOSE

PURPOSE

Pain reliever/fever reducer

INDICATIONS & USAGE

USE(S)

temporarily relieves minor aches and pains due to:

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

temporarily reduces fever

DOSAGE & ADMINISTRATION

DIRECTIONS

do not take more than directed
the smallest effective dose should be used

adults and children 12 years and older

take 1caplet 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

KEEP OUT OF REACH OF CHILDREN

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)

WARNINGS

WARNINGS

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

asthma (wheezing)
blisters
facial swelling
hives
rash
shock
skin reddening

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: NSAID's except aspirin, increases 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.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-993
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE ((CAPLET))	Size	10mm
Flavor		Imprint Code	120
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-993-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020
2	NDC: 11673-993-26	225 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091237	01/01/2020

Labeler - TARGET CORPORATION (006961700)

Registrant - TIME CAP LABORATORIES INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	repack(11673-993)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LTD		925822975	manufacture(11673-993)