IBUPROFEN- ibuprofen tablet, coated 
Kroger Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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601R Ibuprofen Tablets KROGER 41226 601

DRUG FACTS

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose
Pain reliever/Fever reducer

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
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
•if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
•right before or after heart surgery

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 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 this product

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

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.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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

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

Questions or comments? 1-800-632-6900

601R-Kroger-100s-label601R-Kroger-100s-ifc601R-Kroger-24s-label601R-Kroger-250s-label601R-Kroger-200s-label601R-Kroger-50s-label601R-Kroger-50s-ifc601R-Kroger-24s-ifc

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41226-601
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorbrownScoreno score
ShapeROUND (biconvex film coated tablets) Size10mm
FlavorImprint Code TCL;114
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41226-601-421 in 1 CARTON04/10/2021
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:41226-601-051 in 1 CARTON06/12/2021
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:41226-601-011 in 1 CARTON06/12/2021
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:41226-601-20200 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2021
5NDC:41226-601-25250 in 1 BOTTLE; Type 0: Not a Combination Product06/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/10/2021
Labeler - Kroger Company (006999528)
Registrant - Time Cap Laboratories, Inc. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(41226-601)

Revised: 1/2023
Document Id: f158ad51-b771-257f-e053-2a95a90a5558
Set id: bbedfc37-913d-8046-e053-2995a90af68a
Version: 4
Effective Time: 20230103
 
Kroger Company