![IBUPROFEN TABLET, COATED [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]](https://medic.hrt.org//dailymed/images/664cbade-f653-410d-b921-8e5c98cd5678/ibuprofen-200mg-brown-tablet--grn-delisted-1.jpg)
- Active ingredient (in each tablet)
- 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 an seek medical help right away.
Stomach bleeding warning: This product contains an NSAID which may cause sever 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 non-prescription 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
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
- you have problems or serious side effects from taking pain relievers or fever reducers
- the stomach bleeding warning applies to you
- you have a history of stomach problems such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you have asthma
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
- under a doctor's care for any serious condition
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
- the risk of heart attack 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 last more than 10 days
- fever gets worse or last more than 3 days
- redness or swelling is present the painful area
- any new symptoms appear
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Directions
- do not take more than directed
- the smallest effective dose should be used
Adults and children 12 years and older - take 1 tablet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 tablet, 2 tablets may be used
- do not exceed 6 tablets in 24 hours, unless directed by a doctor
Children under 12 years - ask a doctor
:
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Tablets
Ibuprofen Tablets USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)
†Compare to the active ingredient in Advil® Ibuprofen Tablets
Coated Tablets
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil®.
Distributed by: Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
www.valuelabels.com
Product of India
- Package Labeling
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INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-217 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) STARCH, CORN (UNII: O8232NY3SJ) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) MALTODEXTRIN (UNII: 7CVR7L4A2D) POVIDONE K30 (UNII: U725QWY32X) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color BROWN Score no score Shape ROUND Size 10mm Flavor Imprint Code G2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-217-50 1 in 1 BOX 04/13/2013 12/30/2021 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079174 04/13/2013 12/30/2021 Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836) Registrant - P & L Development, LLC (079765031)
