Ibuprofen by is a Otc medication manufactured, distributed, or labeled by H.J. Harkins Company, Inc.. Drug facts, warnings, and ingredients follow.
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:
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
right before or after heart surgery
if you have ever had an allergic reaction to any other pain reliever/fever reducer
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 are taking a diuretic
you have asthma
you have problems or serious side effects from taking pain relievers or fever reducers
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
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 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
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 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,
children under 12 years: ask a doctor
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
MAJOR®
NDC: 0904-7915-80
†Compare to the active ingredient in Advil® Tablets
See New Warnings Information
Ibuprofen
Tablets
Ibuprofen Tablets, USP 200 mg
Pain Reliever
Fever Reducer (NSAID)
1000 COATED TABLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAD UNDER CAP IS BROKEN OR MISSING
50844 REV0910B29116
Distributed by
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA M-17 Rev.11/10
Re-order No. 700643
Product Packaging
IBUPROFEN
ibuprofen tablet, film coated |
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Labeler - H.J. Harkins Company, Inc. (147681894) |
Registrant - H.J. Harkins Company, Inc. (147681894) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
H.J. Harkins Company, Inc. | 147681894 | repack, relabel |