Label: IBUPROFEN capsule, liquid filled
- NDC Code(s): 68210-4205-6
- Packager: SPIRIT PHARMACEUTICALS,LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 7, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each Capsule)
- Purpose
- Uses
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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
Heart attack and stroke warning
NSAID's except aspirin increases the risk of heart attack, heart failure and stroke. These can be fatal. The risk is higher if you use more than directed or longer than directed.
Do not use
- if you have ever had an allergic reaction to any other pain reliever / fever reducer
- right before or after heart surgery
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 stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- under a doctor's care for any serious condition
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
- the risk of heart attach or stroke may increase if you use more than directed or for longer than directed
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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- stomach pain or upset gets worse or lasts
- redness or swelling is present in the painful are
- any new symptoms appear
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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 ad 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 my 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
- 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:68210-4205 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 TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SORBITAN (UNII: 6O92ICV9RU) GELATIN (UNII: 2G86QN327L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN HYDROLYZATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C) ISOPROPYL ALCOHOL (UNII: ND2M416302) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) Product Characteristics Color green Score no score Shape CAPSULE (oblong shaped) Size 18mm Flavor Imprint Code 469 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-4205-6 1 in 1 PACKAGE 07/21/2022 1 6 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 ANDA204469 07/21/2022 Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)