NDC | 65162-770-02, 65162-770-11, 65162-770-50, 65162-770-69 |
Set ID | 5f27dd3f-c735-417b-95e6-26dc5aae5a7a |
Category | HUMAN OTC DRUG LABEL |
Packager | Amneal Pharmaceuticals LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA202300 |
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS AND USAGE
-
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 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
- OTC - DO NOT USE
-
OTC - ASK DOCTOR
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, kidney disease, or asthma
- you are taking a diuretic
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
-
OTC - STOP USE
Stop use and ask a doctor if
- you experience any of the follwing signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- 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
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
-
DOSAGE AND ADMINISTRATION
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
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- OTC – QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IBUPROFEN PAIN RELIEVER/FEVER REDUCER
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65162-770 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 D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SORBITOL (UNII: 506T60A25R) Product Characteristics Color TURQUOISE Score no score Shape CAPSULE Size 18mm Flavor Imprint Code A;77 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65162-770-02 1 in 1 CARTON 12/23/2011 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:65162-770-69 1 in 1 CARTON 12/23/2011 2 80 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:65162-770-11 1000 in 1 BOTTLE; Type 0: Not a Combination Product 12/23/2011 4 NDC:65162-770-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 12/23/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202300 12/23/2011 Labeler - Amneal Pharmaceuticals LLC (123797875) Establishment Name Address ID/FEI Business Operations Amneal Pharmaceuticals of New York, LLC 123797875 ANALYSIS(65162-770, 65162-770) , LABEL(65162-770, 65162-770) , MANUFACTURE(65162-770, 65162-770) , PACK(65162-770, 65162-770)