IBUPROFEN tablet, coated

IBUPROFEN by

Drug Labeling and Warnings

IBUPROFEN by is a Otc medication manufactured, distributed, or labeled by Kroger Company, Time Cap Laboratories, Inc., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Purpose
Pain reliever/Fever reducer

INDICATIONS & USAGE

Uses
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

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: 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.

DO NOT USE

Do not use
if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
right before or after heart surgery

ASK DOCTOR

Ask a doctor before use if
you have problems or serious side effects from taking pain relievers or fever reducers
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, kidney disease, asthma, or had a stroke
you are taking a diuretic

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
under a doctor’s care for any serious condition
taking any other drug

WHEN USING

When using this product

• take with food or milk if stomach upset occurs

STOP USE

Stop use and ask a doctor if
you experience any of the following signs of
stomach bleeding:
feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better
you have symptoms of heart problem or stroke:
chest pain
trouble breathing
weakness in one part or side of the body
slurred speech
leg swelling
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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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

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).

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 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, unless directed by a doctor

children under 12 years:
ask a doctor

OTHER INFORMATION

Other information

• read all warnings and directions before use
• store at 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc,titanium dioxide.

QUESTIONS

Questions or comments? 1-800-632-6900

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IBUPROFEN 
ibuprofen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41226-601
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND (biconvex film coated tablets)	Size	10mm
Flavor		Imprint Code	TCL;114
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41226-601-42	1 in 1 CARTON	04/10/2021
1		24 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 41226-601-05	1 in 1 CARTON	06/12/2021
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 41226-601-01	1 in 1 CARTON	06/12/2021
3		100 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 41226-601-20	200 in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2021
5	NDC: 41226-601-25	250 in 1 BOTTLE; Type 0: Not a Combination Product	06/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/10/2021

Labeler - Kroger Company (006999528)

Registrant - Time Cap Laboratories, Inc. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(41226-601)