IBUPROFEN- ibuprofen capsule, liquid filled 
BIG LOTS STORES, INC.

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Ibuprofen
Capsules, 200 mg
Solubilized Ibuprofen Capsules, 200 mg
Pain Reliever/Fever Reducer (NSAID)

Active Ingridient

(in each capsule)

Solubulised 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

temporarily relieves minor aches and pains due to:

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

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

you have symptoms of heart problems or stroke:

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.

Keep out of reach of children.

Overdose

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

adult and children 12 years and over:

chlidren under 12 years:

Other information

Inactive ingredients

FD&C blue no. 1, FD&C yellow no. 6, gelatin, lecithin (soybean), medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan.

Questions or comments?

call 1-877-770-3183

40 count

IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50594-146
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg  in 200 
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SORBITOL (UNII: 506T60A25R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Product Characteristics
Colorgreen (Green Transparent oblong Capsule Filled with a clear colorless to green solution) Scoreno score
ShapeOVAL (Oblong Capsule) Size19mm
FlavorImprint Code AT146
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50594-146-0440 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20699904/30/2019
Labeler - BIG LOTS STORES, INC. (017885351)

Revised: 12/2020
Document Id: b7b4f650-ec1a-9f62-e053-2995a90aa17a
Set id: 862d926f-a6d3-31e1-e053-2991aa0a6454
Version: 2
Effective Time: 20201230
 
BIG LOTS STORES, INC.