IBUPROFEN- ibuprofen capsule, liquid filled 
WALGREENS

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610T Walgreen 0363-1610 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 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

Ask a doctor or pharmacist before use if you are

When using this product
take with food or milk if stomach upset occurs

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

if pain or fever does not respond to 1 capsule, 2 capsules may be used

do not exceed 6 capsules in 24 hours, unless directed by a doctor

Other information

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

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

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IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1610
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
GELATIN (UNII: 2G86QN327L)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 133
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1610-2320 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/27/2016
2NDC:0363-1610-4440 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/27/2016
3NDC:0363-1610-8080 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/27/2016
4NDC:0363-1610-66160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/27/2016
5NDC:0363-1610-31300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/27/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07920501/27/2016
Labeler - WALGREENS (008965063)
Registrant - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975manufacture(0363-1610)

Revised: 3/2024
Document Id: 13af6333-7380-e54c-e063-6294a90aaa35
Set id: 3ce5b71b-f841-444f-bf66-023e4bd9aa16
Version: 4
Effective Time: 20240315
 
WALGREENS