IBUPROFEN- ibuprofen capsules 200 mg capsule, liquid filled 
TIME CAP LABORATORIES, INC.

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610T Timely 49483-133 Ibuprofen Capsules 200 mg

DRUG FACTS

Active ingredient (in each capsule)
Solubilized Ibuprofen equal to
200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
* nonsteroidal anti-inflammatory drug

Purpose
Pain reliever/Fever reducer

Uses

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

Warnings
Allergy alerts: 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

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better

chest pain
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling

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 use

adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist

children under 12 years: ask a doctor

OTHER INFORMATION

Other information

Inactive ingredients Ammonium hydroxide, FD&C green #3, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, propylene glycol, potassium hydroxide, purified water, shellac, sorbitan monooleate, sorbitol sorbitan

Questions or comments? call 1-877-290-4008

610T-timely-160ct-label610T-timely-ibusgc-label-120s610T-timely-ibusgc-label-80s610T-timely-ibusgc-label-20s610T-timely-ibusgc-ifc-20s610T-timely-ibusgc-200s610T-TCL-Ibuprofen 300mg-bottle label-ct300

IBUPROFEN 
ibuprofen capsules 200 mg capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-133
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
AMMONIA (UNII: 5138Q19F1X)  
GELATIN (UNII: 2G86QN327L)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 133
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-133-31300 in 1 BOTTLE; Type 0: Not a Combination Product07/27/2021
2NDC:49483-133-231 in 1 CARTON06/16/2022
220 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:49483-133-8080 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2022
4NDC:49483-133-12120 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2022
5NDC:49483-133-20200 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2022
6NDC:49483-133-37160 in 1 BOTTLE; Type 0: Not a Combination Product09/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07920507/27/2021
Labeler - TIME CAP LABORATORIES, INC. (037052099)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(49483-133)

Revised: 9/2023
Document Id: 059c51fc-6904-a427-e063-6294a90a7f69
Set id: c7c51cf3-9e95-f8d0-e053-2995a90a7371
Version: 3
Effective Time: 20230918
 
TIME CAP LABORATORIES, INC.