![IBUPROFEN 200MG (383 IBUPROFEN 200MG) TABLET [ALLEGIANT HEALTH]](https://medic.hrt.org//dailymed/images/1d183c6a-4117-4acc-a46c-5ec74d8bbbe2/383---health-a2z-ibuprofen-200mg-1.jpg)
| NDC | 69168-383-01, 69168-383-03, 69168-383-30, 69168-383-40 |
| Set ID | 1d183c6a-4117-4acc-a46c-5ec74d8bbbe2 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Allegiant Health |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA091239 |
- Active ingredient (in each tablet)
- Purpose
- Uses
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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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are 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
- 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
- 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, or kidney disease
- you have asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if
- under a doctor’s care for any serious condition
- taking aspirin for 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
- long term continuous use may increase the risk of heart attack or stroke
Stop use and ask a doctor if
- you feel faint, vomit blood, have bloody or black stools. These are signs of stomach bleeding.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- stomach pain or upset getsworse or lasts
- redness or swelling is present in the painful area
- any new symptoms appear
Pregnancy/Breastfeeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
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Directions
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years 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: ask a doctor
- Other information
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Inactive ingredients
colloidal silicon dioxide, pregelatinized starch, titanium dioxide
May contain: corn starch, croscarmellose sodium, FD&C yellow #6, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, purified water, sodium starch glycolate, stearic acid, talc, triacetin
- Questions or Comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
IBUPROFEN 200MG
383 ibuprofen 200mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-383 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) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BROWN Score no score Shape ROUND Size 10mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-383-40 1 in 1 CARTON 12/23/2014 1 40 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69168-383-30 1 in 1 CARTON 12/23/2014 2 30 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:69168-383-01 1 in 1 CARTON 12/23/2014 3 100 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:69168-383-03 250 in 1 BOTTLE; Type 0: Not a Combination Product 12/23/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091239 12/23/2014 Labeler - Allegiant Health (079501930)
