Label: IBUPROFEN capsule, liquid filled
- NDC Code(s): 69452-239-22
- Packager: Bionpharma Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated September 6, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each orange oval capsule)
- 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 be fatal. The risk is higher if you use more than directed or for longer than directed.
Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month.
- Do not use
-
Ask a doctor before use if
- you have never had migraines diagnosed by a health professional
- you have a headache that is different from your usual migraines
- you have the worst headache of your life
- you have fever and stiff neck
- you have headaches beginning after or caused by head injury, exertion, coughing or bending
- you have experienced your first headache after the age of 50
- you have daily headaches
- you have a migraine so severe as to require bed rest
- 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
- weakness in one part or side of body
- slurred speech
- leg swelling
- migraine headache pain is not relieved or gets worse after the first dose
- any new symptoms appear
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
-
Questions or comments?
call toll free 1-888-235-2466
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
†All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Advil® Migraine.
Manufactured for:
Bionpharma Inc.
600 Alexander Road,
Princeton, NJ 08540
Rev # 07/19
L0000230
- 120's Bottle lable
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69452-239 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 FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color orange Score no score Shape OVAL Size 20mm Flavor Imprint Code IB2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69452-239-22 120 in 1 BOTTLE; Type 0: Not a Combination Product 08/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078682 08/02/2019 Labeler - Bionpharma Inc. (079637826) Registrant - Bionpharma Inc. (079637826) Establishment Name Address ID/FEI Business Operations Patheon Softgels Inc. 002193829 manufacture(69452-239)