NDC | 25000-133-01, 25000-133-04, 25000-133-13, 25000-133-18, 25000-133-23, 25000-133-43 |
Set ID | 403ec259-3be1-4e0b-ab7b-fee213b7eabe |
Category | Human OTC Drug Label |
Packager | MARKSANS PHARMA LIMITED |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA079205 |
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
-
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 nonsteroidal anti - inflammatory drug (NSAIDs), 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.
Heart 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
-
ASK A DOCTOR BEFORE USE IF
- the stomach bleeding warning applies to you
- you have problems or serious side effects from taking pain relievers or fever reducers
- 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
- 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
- OTHER REQUIRED WARNINGS
- PREGNANCY/BREASTFEEDING
- 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 and over: take 1 capsule every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 capsule, 2 capsules may be used
- do not exceed 6 capsules in 24 hours, unless directed by a doctor
- children under 12 years: ask a doctor
- INACTIVE INGREDIENTS
- STORAGE
-
PRINCIPAL DISPLAY PANEL
Ibuprofen capsules 200 mg (liquid filled Capsules)
10's bottle label
NDC 25000-133-4310's carton label
NDC 25000-133-4320's bottle label
NDC 25000-133-0120's carton label
NDC 25000-133-0132's bottle label
NDC 25000-133-0432's Carton Label
NDC 25000-133-04600's bottle label
NDC 25000-133-13300's bottle label
NDC 25000-133-69Ibuprofen capsules 200 mg (mini liquid filled)
10's bottle label
NDC 25000-062-4310's carton label
NDC 25000-062-4320's bottle label
NDC 25000-062-0120's carton label
NDC 25000-062-0132's bottle label
NDC 25000-062-0432's carton label
NDC 25000-062-0480's bottle label
NDC 25000-062-6780's carton label
NDC 25000-062-67600's bottle label
NDC 25000-062-13 -
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-133 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 AMMONIA (UNII: 5138Q19F1X) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) FERROUS OXIDE (UNII: G7036X8B5H) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Product Characteristics Color GREEN Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 133 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25000-133-23 5 in 1 DRUM 09/01/2017 1 2000 in 1 BAG; Type 0: Not a Combination Product 2 NDC:25000-133-18 4 in 1 BOX 09/01/2017 2 2500 in 1 BAG; Type 0: Not a Combination Product 3 NDC:25000-133-04 1 in 1 CARTON 09/01/2017 3 32 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:25000-133-13 1 in 1 BOX 09/01/2017 4 600 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:25000-133-43 1 in 1 CARTON 09/01/2017 5 10 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:25000-133-01 1 in 1 CARTON 09/01/2017 6 20 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:25000-133-69 300 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079205 09/01/2017 IBUPROFEN
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-062 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 AMMONIA (UNII: 5138Q19F1X) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) FERROUS OXIDE (UNII: G7036X8B5H) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Product Characteristics Color GREEN Score no score Shape CAPSULE Size 6mm Flavor Imprint Code 62 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25000-062-43 1 in 1 CARTON 08/18/2020 1 10 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:25000-062-01 01 in 1 CARTON 08/18/2020 2 20 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:25000-062-04 1 in 1 CARTON 08/18/2020 3 32 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:25000-062-67 1 in 1 CARTON 08/18/2020 4 80 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:25000-062-13 600 in 1 BOTTLE; Type 0: Not a Combination Product 08/18/2020 6 NDC:25000-062-87 1 in 1 BOX 08/18/2020 6 2500 in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079205 08/18/2020 Labeler - MARKSANS PHARMA LIMITED (925822975) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 MANUFACTURE(25000-062, 25000-133)