![IBUPROFEN TABLET, COATED [FAMILY DOLLAR (FAMILY WELLNESS)]](https://medic.hrt.org//dailymed/images/7dc46067-a6d2-4f4e-9c4e-9323c943b5db/ibuprofen-200-mg-brown-caplet-grn-delisted-1.jpg)
| NDC | 55319-661-10, 55319-661-25, 55319-661-50 |
| Set ID | 7dc46067-a6d2-4f4e-9c4e-9323c943b5db |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Family Dollar (FAMILY WELLNESS) |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA079174 |
- 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 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 g=higher if you use more than directed or for 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
- you have problems or serious side effects from taking pain relievers or fever reducers
- stomach bleeding warning applies to you
- you have a history of stomach problems such as heartburm
- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a astroke
- 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
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- 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 in the painful area
- any new symptoms appear
-
Directions
- do not take more than directed
- the smallest effective dose should be used
- adults and children 12 years and older:
- 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
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Compare to the active ingredient in Advil® Caplets†
See new warnings
Ibuprofen
Tablets USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)
CAPLETS**
(**CAPSULE-SHAPED TABLETS)
Product of India
†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil®.
DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY:MIDWOOD BRANDS, LLC
10611 MONROE RD, MATTHEWS, NC 28105
- Package Label
-
INGREDIENTS AND APPEARANCE
IBUPROFEN
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-661 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) FERRIC OXIDE RED (UNII: 1K09F3G675) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color brown Score no score Shape CAPSULE Size 15mm Flavor Imprint Code G2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-661-50 1 in 1 BOX 10/05/2017 04/26/2024 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:55319-661-10 1 in 1 BOX 10/05/2017 04/26/2024 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:55319-661-25 250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/05/2017 04/26/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079174 10/05/2017 04/26/2024 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
