NDC | 69230-146-20, 69230-146-40, 69230-146-52, 69230-146-80 |
Set ID | b5affa01-736a-463b-b7ee-ddd9db129312 |
Category | Human OTC Drug Label |
Packager | Camber Consumer Care. Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA206999 |
- Active ingredient
- PURPOSE
- 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
- skin reddening
- rash
- blisters
If an allergic reaction occurs, stop use and 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 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
- 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
. slurred speech
. leg swelling
. weakness in one part or side of body
- 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
- PREGNANCY OR BREAST FEEDING
- 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 1capsule, 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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69230-146 Route of Administration ORAL, 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color GREEN Score no score Shape OVAL Size 20mm Flavor Imprint Code AT146 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69230-146-20 1 in 1 CARTON 05/01/2018 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69230-146-40 1 in 1 CARTON 05/01/2018 2 40 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:69230-146-80 1 in 1 CARTON 05/01/2018 3 80 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:69230-146-52 1 in 1 CARTON 05/01/2018 4 160 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206999 05/01/2018 Labeler - Camber Consumer Care. Inc. (079539968)