- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT (in each tablet)
- PURPOSE
- USES
-
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
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- take more or for longer time than directed
Heart attack and stroke warning: NSAIDs, except aspirin, increases 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
-
ASK 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 and 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 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
- you experience and of the following signs of stomach bleeding:
- If PREGNANT OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- do not take more than directed
- the smallest effective dose should be used
Adults and children 12 years of age and over:
■ 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 of age: ■ Ask a doctor
- SPL UNCLASSIFIED SECTION
-
INACTIVE INGREDIENTS
(White) Carnauba Wax, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.
(Orange) Croscarmellose Sodium, FD&C Yellow #6 Lake, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc and Titanium Dioxide.
(Brown) Croscarmellose Sodium, Hydroxypropylcellulose, Hypromellose, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch, Red Iron Oxide, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, and Titanium Dioxide.
- QUESTIONS or COMMENTS?
- SPL UNCLASSIFIED SECTION
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
See New Warnings
CONTRACT PHARMACAL CORP NDC 10267-3909-2
**Compares to the active ingredient in Motrin ®IB
GLUTEN FREEIbuprofen Tablets, USP 200 mg
Pain Reliever/Fever Reducer
(NSAID)
250 Coated Tablets
DYE-FREE
NOT ACTUAL SIZESee New Warnings
CONTRACT PHARMACAL CORP NDC 10267-3846-2
**Compares to the active ingredient in Motrin ®IB
GLUTEN FREEIbuprofen Tablets, USP 200 mg
Pain Reliever/Fever Reducer
(NSAID)
250 Coated Tablets
NOT ACTUAL SIZESee New Warnings
CONTRACT PHARMACAL CORP NDC 10267-3852-2
**Compares to the active ingredient in Motrin ®IB
GLUTEN FREEIbuprofen Tablets, USP 200 mg
Pain Reliever/Fever Reducer
(NSAID)
250 Coated Tablets
NOT ACTUAL SIZE -
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10267-3852 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STARCH, CORN (UNII: O8232NY3SJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSES (UNII: 3NXW29V3WO) Product Characteristics Color brown Score no score Shape ROUND (convex) Size 6mm Flavor Imprint Code C1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10267-3852-2 250 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA071265 01/15/2014 IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10267-3846 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STARCH, CORN (UNII: O8232NY3SJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYVINYL ALCOHOL (UNII: 532B59J990) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape ROUND (convex) Size 6mm Flavor Imprint Code C1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10267-3846-2 250 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA071265 01/15/2014 IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10267-3909 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STARCH, CORN (UNII: O8232NY3SJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CARNAUBA WAX (UNII: R12CBM0EIZ) Product Characteristics Color white Score no score Shape ROUND (convex) Size 6mm Flavor Imprint Code C1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10267-3909-2 250 in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA071265 01/15/2014 Labeler - Contract Pharmacal Corp. (057795122) Registrant - Contract Pharmacal Corp. (057795122) Establishment Name Address ID/FEI Business Operations Contract Pharmacal Corp. 057795122 pack(10267-3852, 10267-3846, 10267-3909) Establishment Name Address ID/FEI Business Operations Contract Pharmacal Corp. 968334974 manufacture(10267-3852, 10267-3846, 10267-3909) Establishment Name Address ID/FEI Business Operations Contract Pharmacal Corp. 968335112 manufacture(10267-3852, 10267-3846, 10267-3909)