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| NDC | 63548-0185-1, 63548-0185-2, 63548-0185-3 |
| Set ID | c6dcc329-bab5-41ab-94e7-625e07628fd6 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | PLD Acquisitions LLC DBA Avéma Pharma Solutions |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA076460 |
- Active Ingredient (in each caplet)
- 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
- rash
- blisters
- skin reddening
If an allergic reaction occurs, stop use an 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 oder
- have had stomach ulcers or bleeding problems
- take blood thinning (anticoagulant) or steroid drug
- take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- take more or for a longer time than directed.
- have 3 or more alcoholic drinks every day while using this prdouct
Do not use
- if you 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 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, or kidney disease
- you have 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 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
- 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
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- pain gets worse or last more than 10 days
- fever gets worse or last more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
If pregnant or breast-feeding
ask a health professional before use. It is especially important not to use ibuprofen druing the last 3 months of pegnancy unless defintely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Directions
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and older:
- take 1 caplet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 caplet, 2 caplets may be used
- do not exceed 6 caplets in 24 hours, unless directed by a doctor
- children under 12 years : ask a doctor
- Inactive Ingredients
- Questions or comments?
-
Principal Display Panel
Ibuprofen Tablets USP, 200 mg
Pain Reliever/ Fever Reducer (NSAID)
Coated Caplets**
**(Capsule-Shaped Tablets)
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING
Manufactured by: Avema Pharma Solutions
10400 NW 29th Terrace
Miami, FL 33172
- Product Label
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63548-0185 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 CARNAUBA WAX (UNII: R12CBM0EIZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) ALUMINUM OXIDE (UNII: LMI26O6933) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 14mm Flavor Imprint Code 55 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63548-0185-2 1 in 1 BOX 08/01/2013 1 100 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:63548-0185-1 10 in 1 VIAL; Type 0: Not a Combination Product 08/01/2013 3 NDC:63548-0185-3 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076460 08/01/2013 Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)
