Label: ASSURED IBUPROFEN- ibuprofen tablet, film coated
- NDC Code(s): 68210-4139-4
- Packager: Spirit Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 10, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each caplet)
- 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 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
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Do not use
-
Ask a doctor before use if
¬ the 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
- SPL UNCLASSIFIED SECTION
- STOP USE
- PREGNANCY OR BREAST FEEDING
-
Directions
¬ do not take more than directed
¬ the smallest effective dose should be used
¬ do not take longer than 10 days, unless directed by a
doctor (see Warnings)
¬ adults and children 12 years and over: 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 - Other information
- SPL UNCLASSIFIED SECTION
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ASSURED IBUPROFEN
ibuprofen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4139 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape CAPSULE Size 10mm Flavor Imprint Code G2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-4139-4 1 in 1 CARTON 04/28/2021 1 40 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202312 02/25/2019 Labeler - Spirit Pharmaceuticals LLC (179621011)