Label: IBUPROFEN- ibuprofen capsules 200 mg capsule, liquid filled
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NDC Code(s):
49483-133-12,
49483-133-20,
49483-133-23,
49483-133-31, view more49483-133-37, 49483-133-80
- Packager: TIME CAP LABORATORIES, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 18, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Allergy alerts: 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
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ASK DOCTOR
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 DOCTOR/PHARMACIST
- WHEN USING
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STOP USE
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- 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
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DOSAGE & ADMINISTRATION
Directions
do not take more than directed
the smallest effective dose should be use
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 1 capsule, 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 INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen capsules 200 mg capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-133 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 WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) AMMONIA (UNII: 5138Q19F1X) GELATIN (UNII: 2G86QN327L) FERROSOFERRIC OXIDE (UNII: XM0M87F357) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SORBITOL (UNII: 506T60A25R) Product Characteristics Color green Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 133 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-133-31 300 in 1 BOTTLE; Type 0: Not a Combination Product 07/27/2021 2 NDC:49483-133-23 1 in 1 CARTON 06/16/2022 2 20 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:49483-133-80 80 in 1 BOTTLE; Type 0: Not a Combination Product 06/16/2022 4 NDC:49483-133-12 120 in 1 BOTTLE; Type 0: Not a Combination Product 06/16/2022 5 NDC:49483-133-20 200 in 1 BOTTLE; Type 0: Not a Combination Product 06/16/2022 6 NDC:49483-133-37 160 in 1 BOTTLE; Type 0: Not a Combination Product 09/16/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079205 07/27/2021 Labeler - TIME CAP LABORATORIES, INC. (037052099) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(49483-133)