IBUPROFEN- ibuprofen tablet, film coated 
IBUPROFEN- ibuprofen tablet, film coated 
TIME CAP LABORATORIES,INC

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IBUPROFEN TABLETS USP 200MG ROUND BROWN

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:

o headache
o toothache
o backache
o menstrual cramps
o the common cold
o muscular aches
o minor pain of arthritis

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 severe 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

• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• 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

• under a doctor’s care for any serious condition
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• 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 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:

children under 12 years:

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? call 1-877-290-4008

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IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-114
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
STARCH, CORN (UNII: O8232NY3SJ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorbrownScoreno score
ShapeROUND (Biconvex) Size10mm
FlavorImprint Code 114
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-114-50500 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2021
2NDC:49483-114-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2021
3NDC:49483-114-17200 in 1 BOTTLE; Type 0: Not a Combination Product08/19/2023
4NDC:49483-114-73100 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123903/22/2016
IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-601
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorbrownScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code 114
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-601-006500 in 1 BAG; Type 0: Not a Combination Product03/22/2016
2NDC:49483-601-0550 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2016
3NDC:49483-601-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2016
4NDC:49483-601-50500 in 1 BOTTLE; Type 0: Not a Combination Product03/22/201608/07/2021
5NDC:49483-601-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/22/201608/07/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123903/22/2016
IBUPROFEN 
ibupfrofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-600
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorbrownScore2 pieces
ShapeCAPSULESize15mm
FlavorImprint Code 117
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-600-0550 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2016
2NDC:49483-600-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2016
3NDC:49483-600-50500 in 1 BOTTLE; Type 0: Not a Combination Product11/14/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123903/22/2016
Labeler - TIME CAP LABORATORIES,INC (037052099)
Registrant - TIME CAP LABORATORIES,INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(49483-601, 49483-600, 49483-114)

Revised: 11/2023
Document Id: 0aca78a6-495e-bdd8-e063-6294a90ad0b3
Set id: f58d35f9-e44b-417b-98ce-0766b537cd2f
Version: 11
Effective Time: 20231122
 
TIME CAP LABORATORIES,INC