601R TARGET - IBUPROFEN 200 MG TABLETS 11673-991

601R TARGET - IBUPROFEN 200 MG TABLETS 11673-991

Drug Labeling and Warnings

Drug Details

k">

IBUPROFEN- ibuprofen tablet, coated 
TARGET CORPORATION

----------

601R TARGET - IBUPROFEN 200 MG TABLETS 11673-991

ACTIVE INGREDIENT(S)

Ibuprofen 200 mg (NSAID)*

* nonstreoidal anti-inflammatory drug

INACTIVE INGREDIENTS

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

PURPOSE

Pain reliever / fever reducer

USE(S)

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

DIRECTIONS

do not take more than directed
the smallest effective dose should be used

adults and children 12 years and older

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

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

WARNINGS

Allergy alerts: 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 drug containing prescription NSAID (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.

50ct

100ct

200ct

500ct 094-01-0142

601R 2x500 SLEEVE

IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11673-991
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: 11673-991-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/04/2020
2NDC: 11673-991-0550 in 1 BOTTLE; Type 0: Not a Combination Product02/04/2020
3NDC: 11673-991-26200 in 1 BOTTLE; Type 0: Not a Combination Product02/04/2020
4NDC: 11673-991-50500 in 1 BOTTLE; Type 0: Not a Combination Product02/04/2020
5NDC: 11673-991-881000 in 1 BOTTLE; Type 0: Not a Combination Product02/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123902/04/2020
Labeler - TARGET CORPORATION (006961700)
Registrant - TIME CAP LABORATORIES INC (037005209)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC.037052099repack(11673-991)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LTD925822975manufacture(11673-991)

Revised: 1/2020
 
TARGET CORPORATION


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.