IBUPROFEN- ibuprofen tablet, coated 
RITE AID CORPORATION

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601R RITE AID 11822 7892 IBUPROFEN 200 MG TABLETS

DRUG FACTS

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonstreoidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses

temporarily relieves minor aches and pains due to :

temporarily reduces fever

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you:

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

Ask a doctor before use if

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:

you have symptoms of heart problem or stroke:

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 during the last 3 months of 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:

children under 12 years:

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? Call 1-877-290-4008

601R-Rite Aid-Ibuprofen 200mg round (brown)-carton label-50s601R-Rite Aid-Ibuprofen 200mg round (brown)-bottle label-200s601R-Rite Aid-Ibuprofen 200mg round (brown)-carton label-200s601R-Rite Aid-Ibuprofen 200mg round (brown)-bottle label-100s601R-Rite Aid-Ibuprofen 200mg round (brown)-carton label-100s601R-Rite Aid-Ibuprofen-200mg round (brown)-bottle label-500s601R-Rite Aid-Ibuprofen 200mg round (brown)-bottle label-50s601R-Rite Aid-Ibuprofen 200mg round (brown)-bottle label-24s601R-Rite Aid-Ibuprofen 200mg round (brown)-carton label-24s

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-7892
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)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 114
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-7892-5100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
2NDC:11822-7892-024 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
3NDC:11822-7892-9500 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
4NDC:11822-7892-250 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
5NDC:11822-7892-7200 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123906/01/2020
Labeler - RITE AID CORPORATION (014578892)
Registrant - TIME CAP LABORATORIES INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LTD925822975manufacture(11822-7892)

Revised: 10/2021
Document Id: cf2caf6f-2192-2428-e053-2995a90aae6d
Set id: a7abac4c-7695-cfe8-e053-2a95a90ac1cd
Version: 2
Effective Time: 20211030
 
RITE AID CORPORATION