IBUPROFEN capsule, liquid filled

IBUPROFEN by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Solubilized Ibuprofen equal to
200 mg ibuprofen (NSAID)*

(present as the free acid and potassium salt)

* nonsteroidal anti-inflammatory drug

INACTIVE INGREDIENT

AMMONIA, FD&C GREEN #3, GELATIN, FERROSOFERRIC OXIDE, MEDIUM CHAIN TRIGLYCERIDES, POLYETHYLENE GLYCOL, PROPYLENE GLYCOL, POTASSIUM HYDROXIDE, WATER, SHELLAC, SORBITAN MONOOLEATE, SORBITAN

DOSAGE & ADMINISTRATION

DO NOT TAKE MORE THAN DIRECTED

THE SMALLEST EFFECTIVE DOSE SHOULD BE USED

DRINK A FULL GLASS OF WATER WITH EACH DOSE

INDICATIONS & USAGE

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

PURPOSE

PAIN RELIEVER/ FEVER REDUCER

WARNINGS

Allergy alerts: 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

KEEP OUT OF REACH OF CHILDREN

IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1610
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
AMMONIA (UNII: 5138Q19F1X)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
GELATIN (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITAN (UNII: 6O92ICV9RU)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1610-23	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/27/2016
2	NDC: 0363-1610-44	40 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/27/2016
3	NDC: 0363-1610-80	80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/27/2016
4	NDC: 0363-1610-66	160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/27/2016
5	NDC: 0363-1610-31	300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/27/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA079205	01/27/2016

Labeler - WALGREENS (008965063)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(0363-1610)