- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
-
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
-
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*, polyvinyl alcohol, 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
ZEE IBUTAB
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35418-751 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL (UNII: 532B59J990) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color brown (chocolate brown) Score no score Shape ROUND Size 10mm Flavor Imprint Code 114 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35418-751-69 500 in 1 CARTON 04/13/2018 1 NDC:35418-751-67 125 in 1 CARTON 1 NDC:35418-751-68 50 in 1 CARTON 1 NDC:35418-751-02 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 ANDA079174 09/10/2015 Labeler - Zee Medical Inc (009645623) Registrant - Ultra Seal Corporation (085752004) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 repack(35418-751)