Label: IBUTAB- ibuprofen tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 35418-750-02, 35418-750-67, 35418-750-68, 35418-750-69 - Packager: Zee Medical Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 1, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
DOSAGE & ADMINISTRATION
Directions
- do not take more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless directed by a doctor (see Warnings)
- adults: 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
- children under 12 years: ask a doctor
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WARNINGS
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
■ rash ■ skin reddening ■ blisters
If an allergic reaction occurs, stop use and seek medical help
right away.
Stomach bleeding warning: This product contains a
nonsteroidal anti-inflammatory drug (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
■ 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
Do not use
■ if you have ever had an allergic reaction to any other pain
reliever/fever reducer
■ right before or after heart surgery
Ask a doctor before use if
■ stomach bleeding warning applies to you
■ you have a history of stomach problems, such as heartburn
■ you have problems or serious side effects from taking pain
relievers or fever reducers
■ you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, or asthma
■ you are taking a diuretic
Ask a doctor or pharmacist before use if you are
■ under a doctor's care for any serious condition
■ taking aspirin to prevent heart attack or stroke, because
ibuprofen may decrease this benefit of aspirin
■ taking any other drug
When using this product
■ take with food or milk if stomach upset occurs
■ the risk of heart attack or stroke may increase if you use more
than directed or for longer than directed
Stop 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
■ 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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Inactive ingredients carnauba wax*, cellulose,
croscarmellose sodium*, DC yellow 10*, FDC blue 2*, FDC
red 40*, FDC yellow 6*, hydroxypropyl methylcellulose,
magnesium stearate, maltodextrin*, polyethylene glycol*,
polysorbate 80*, red iron oxide, silicon dioxide, sodium starch
glycolate*, starch*, talc*, titanium dioxide, triacetin*
*Contains one or more of these ingredients.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IBUTAB
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35418-750 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 CARNAUBA WAX (UNII: R12CBM0EIZ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color brown (chocolate brown) Score no score Shape ROUND (IBU;200) Size 110mm Flavor Imprint Code IBU;200 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35418-750-69 500 in 1 CARTON 06/12/2012 1 NDC:35418-750-67 125 in 1 CARTON 1 NDC:35418-750-68 50 in 1 CARTON 1 NDC:35418-750-02 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079129 06/12/2012 Labeler - Zee Medical Inc (009645623) Registrant - Ultra Seal Corporation (085752004) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 pack(35418-750)