IBUPROFEN 200MG- ibuprofen 200mg tablet, film coated 
Southern Sales & Services, Inc.

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Ibuprofen 200mg 50 tablet

Directions

Adults and children 12 years and older:

Children under 12 years: ask a doctor

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 chances are higher if you

Inactive ingredients

colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide

Uses

Temporarily relieves minor aches and pains due to:

Keep out of reach of children.

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

Purposes

Pain reliever/fever reducer

Active ingredient (in each tablet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory dru

Don 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:

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.

Other information

Ibuprofen 200mg 50 Tablets

Ibuprofen

IBUPROFEN 200MG 
ibuprofen 200mg tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-693(NDC:0904-6747)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize10mm
FlavorImprint Code I2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69822-693-5050 in 1 BOTTLE; Type 0: Not a Combination Product10/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07209610/31/2022
Labeler - Southern Sales & Services, Inc. (013114906)

Revised: 10/2022
Document Id: ec578861-5a51-5362-e053-2995a90ab54a
Set id: ec578861-5a50-5362-e053-2995a90ab54a
Version: 1
Effective Time: 20221031
 
Southern Sales & Services, Inc.