Label: IBUPROFEN 200MG tablet, film coated
- NDC Code(s): 69822-693-50
- Packager: Southern Sales & Services, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-6747
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 31, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
-
Directions
- do not take more than directed
- the smallest effective dose should be used
Adults and children 12 years and older:
- take 1 tablet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 tablet, 2 tablets may be used
- do not exceed 6 tablets in 24 hours, unless directed by a doctor
Children under 12 years: ask a doctor
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Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters
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
- are age 60 or older
- have had stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
- have 3 or more alcoholic drinks every day while using this product
- take more or for a longer time than directed
- Inactive ingredients
- Uses
- Keep out of reach of children.
- Purposes
- Active ingredient (in each tablet)
- Don not use
-
Ask a doctor before use if
- you have problems or serious side effects from taking pain relievers or fever reducers
- the stomach bleeding warning applies to you
- 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
- When using this product
-
Stop use and ask a doctor if
you experience any of the following signs of stomach bleeding:
- feel faint
- vomitblood
- have bloody or black stools
- have stomach pain that does not get better
- you have symptoms of heart problems or stroke: chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- 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
- Other information
- Ibuprofen 200mg 50 Tablets
-
INGREDIENTS AND APPEARANCE
IBUPROFEN 200MG
ibuprofen 200mg tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69822-693(NDC:0904-6747) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength 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 Color brown Score no score Shape ROUND Size 10mm Flavor Imprint Code I2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69822-693-50 50 in 1 BOTTLE; Type 0: Not a Combination Product 10/31/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA072096 10/31/2022 Labeler - Southern Sales & Services, Inc. (013114906)