IBUPROFEN by WALGREENS / TIME CAP LABORATORIES, INC / MARKSANS PHARMA LIMITED IBUPROFEN tablet

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

ibuprofen 200 mg CAPLETS 612R INACTIVE INGREDIENTS

Colloidal silicon dioxide, croscarmellose sodium,FD&C Yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

DOSAGE & ADMINISTRATION

DO NOT TAKE MORE THAN DIRECTED

THE SMALLEST EFFECTIVE DOSE SHOULD BE USED

Adults and children 12 years and over:

• take 1 caplet every 4 to 6 hours while symptom persist
• If pain 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

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 alert: Ibuprofen may cause a severe allergy 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 a NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older
have bad stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
the 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 longer than directed.

KEEP OUT OF REACH OF CHILDREN

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

50 COUNT 612R

100 COUNT 612R

225 COUNT 612R

500 COUNT 612R

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9612
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH 1500, PREGELATINIZED (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9612-05	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/11/2018
2	NDC: 0363-9612-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/11/2018
3	NDC: 0363-9612-26	225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/11/2018
4	NDC: 0363-9612-50	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/11/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091237	12/11/2018

Labeler - WALGREENS (008965063)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(0363-9612)