IBUPROFEN capsule, liquid filled

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

ACTIVE INGREDIENT(S)

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

INACTIVE INGREDIENT

INACTIVE INGREDIENTS

Ammonium Hydroxide, FD&C Green No. 3, Gelatin, Iron oxide black, Medium-chain triglycerides, Polyethylene glycol, Propylene glycol, Potassium hydroxide, Purified water, Shellac, Sorbitol sorbitan, Sorbitan monooleate.

PURPOSE

PURPOSE

Pain reliever/Fever reducer

*nonsteroidal anti-inflammatory drug

INDICATIONS & USAGE

USE(S)

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 & ADMINISTRATION

DIRECTIONS

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

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.

WARNINGS

WARNINGS

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 a nonsteroidal anti-inflammatory drug (NSAIDs), 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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-992
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
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMMONIA (UNII: 5138Q19F1X)
FERROUS OXIDE (UNII: G7036X8B5H)
GELATIN (UNII: 2G86QN327L)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	133
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11673-992-44	40 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020
2	NDC: 11673-992-80	80 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	ANDA079205	01/01/2020

Labeler - TARGET CORPORATION (006961700)

Registrant - TIME CAP LABORATORIES, INC (037005209)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	repack(11673-992)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LTD		925822975	manufacture(11673-992)