NDC | 25000-114-03, 25000-114-14, 25000-114-20, 25000-114-30, 25000-114-93, 25000-114-98, 25000-117-03, 25000-117-14, 25000-117-20, 25000-117-30, 25000-117-93, 25000-117-98 |
Set ID | 3c8df1e5-61bc-4e70-b6b9-8973986ad589 |
Category | Human OTC Drug Label |
Packager | MARKSANS PHARMA LIMITED |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA091239 |
- Active ingredient(s)
- Purpose
- Use(s)
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Warnings
Allergy alert: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.
Symptoms may include:- asthma (wheezing)
- blisters
- facial swelling
- hives
- rash
- shock
- skin reddening
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains a NSAID, which may cause severe stomach bleeding. The chance is higher if you:- are age 60 or older
- have bad stomach ulcers or bleeding problems
- take a blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- have 3 or more alcoholic drinks every day while using this product
- the more or for a longer time than directed
Heart attack and stroke warning: NSAID's 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 longer than directed.
- Do not use
-
Ask 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 a high blood pressure, heart disease,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 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 problem 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 painful area
- any new symptoms appear
- 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 older - 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 - ask a doctor
- Other information
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Inactive ingredients
Silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide.
Questions or Comments?
Call 1-877-290-4008
Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA
Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Industrial Estate
Verna, Goa-403722, India - Storage
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Principal Display Panel
Ibuprofen Tablets USP, 200mg
30 counts
Bottle LabelIbuprofen Tablets USP, 200mg
30 counts
Carton LabelIbuprofen Tablets USP, 200mg (Caplets)
30 counts
Bottle LabelIbuprofen Tablets USP, 200mg (Caplets)
30 counts
Carton LabelIbuprofen Tablets USP, 200mg
500 counts
Bottle LabelIbuprofen Tablets USP, 200mg
1000 counts
Bottle LabelIbuprofen Tablets USP, 200mg (Caplets)
300 counts
Bottle Label -
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-114 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) POLYVINYL ALCOHOL (UNII: 532B59J990) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) Product Characteristics Color 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:25000-114-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/25/2011 2 NDC:25000-114-14 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/25/2011 3 NDC:25000-114-20 4 in 1 BOX 07/25/2011 3 6500 in 1 BAG; Type 0: Not a Combination Product 4 NDC:25000-114-30 6 in 1 BOX 07/25/2011 4 6500 in 1 BAG; Type 0: Not a Combination Product 5 NDC:25000-114-98 1 in 1 BOX 07/25/2011 5 34065 in 1 BAG; Type 0: Not a Combination Product 6 NDC:25000-114-93 1 in 1 BOX 07/25/2011 6 37470 in 1 BAG; Type 0: Not a Combination Product 7 NDC:25000-114-70 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/25/2011 8 NDC:25000-114-71 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/25/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091239 07/25/2011 IBUPROFEN
ibuprofen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-117 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FERRIC OXIDE RED (UNII: 1K09F3G675) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) POLYVINYL ALCOHOL (UNII: 532B59J990) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) Product Characteristics Color BROWN Score no score Shape CAPSULE Size 15mm Flavor Imprint Code 117 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25000-117-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/25/2011 2 NDC:25000-117-14 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/25/2011 3 NDC:25000-117-20 4 in 1 BOX 07/25/2011 3 6500 in 1 BAG; Type 0: Not a Combination Product 4 NDC:25000-117-30 6 in 1 BOX 07/25/2011 4 6500 in 1 BAG; Type 0: Not a Combination Product 5 NDC:25000-117-98 1 in 1 BOX 07/25/2011 5 34065 in 1 BAG; Type 0: Not a Combination Product 6 NDC:25000-117-93 1 in 1 BOX 07/25/2011 6 37470 in 1 BAG; Type 0: Not a Combination Product 7 NDC:25000-117-69 300 in 1 BOTTLE; Type 0: Not a Combination Product 07/25/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091239 07/25/2011 Labeler - MARKSANS PHARMA LIMITED (925822975) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 LABEL(25000-117) , MANUFACTURE(25000-114, 25000-117)