Label: IBUPROFEN capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 50594-146-04 - Packager: BIG LOTS STORES, INC.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 30, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingridient
- Purpose
- Uses
- Allergy Alert
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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
- Do not use
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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
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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
- weakness in one part or side of body
- leg swelling
- 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
- If pregnant or breast-feeding
- Keep out of reach of children.
- Overdose
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Directions
- do not take more than directed
- the smallest effective dose should be used
adult 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
chlidren under 12 years:
- ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50594-146 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg in 200 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SORBITOL (UNII: 506T60A25R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Product Characteristics Color green (Green Transparent oblong Capsule Filled with a clear colorless to green solution) Score no score Shape OVAL (Oblong Capsule) Size 19mm Flavor Imprint Code AT146 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50594-146-04 40 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206999 04/30/2019 Labeler - BIG LOTS STORES, INC. (017885351)