Label: MOTRIN IB- ibuprofen tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 73097-008-02, 73097-008-40, 73097-008-50 - Packager: Savings Distributors LLC
- This is a repackaged label.
- Source NDC Code(s): 50580-110
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated July 11, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each caplet)
- Uses
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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 chance is higher if you:
■ are age 60 or older
■ have had stomach ulcers or bleeding problems
■ ake 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 directedHeart 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
■ if you have ever had an allergic reaction to any other pain reliever/fever reducer
■ right before or after heart surgeryAsk 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, or kidney disease
■ you have asthma
■ you are taking a diureticAsk a doctor or pharmacist before use if you are
■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
■ under a doctor’s care for any serious condition
■ taking any other drugStop use and ask a doctor if
■ you experience any of the following signs of stomach bleeding:
■ feel faint ■ vomit blood ■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 the 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 -
Directions
■ do not take more than directed
■ the smallest effective dose should be usedadults and children 12 years and older ■ take 1 caplet every 4 to 6 hours while symptoms persist
■ if pain or fever does not respond to 1 caplet, 2 caplets may be used
■ do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years ■ ask a doctor
- Other information
- Inactive ingredients
- Questions or Comments?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
MOTRIN IB
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73097-008(NDC:50580-110) 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 STARCH, CORN (UNII: O8232NY3SJ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) TALC (UNII: 7SEV7J4R1U) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C RED NO. 40 (UNII: WZB9127XOA) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color orange Score no score Shape OVAL Size 16mm Flavor Imprint Code Motrin;IB Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73097-008-02 1 in 1 CARTON 07/05/2019 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:73097-008-40 20 in 1 CARTON 07/05/2019 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:73097-008-50 25 in 1 CARTON 07/05/2019 3 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019012 07/05/2019 Labeler - Savings Distributors LLC (010527359)
