FDA Label for Henry Schein Ibuprofen
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE US IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- OTC - QUESTIONS
- HENRY SCHEIN PDP
Henry Schein Ibuprofen Product Label
The following document was submitted to the FDA by the labeler of this product Henry Schein Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
temporarily relieves minor aches and pains due to
- headache
- the common cold
- toothache
- muscular aches
- backache
- menstrual cramps
- minor pain of arthritis
temporarily reduces fever
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
■ hives ■ skin reddening ■ asthma (wheezing) ■ facial swelling ■ rash ■ shock ■ 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
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 Us 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 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 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 for more than 10 days
■ fever gets worse or lasts for more than 3 days
■ redness or swelling is present in the painful area
■ any new or unexpected symptoms occur
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
■ do not use 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 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:
Do not give to children under 12 years of age.
Other Information
■ read all product information before using
■ store at 68-77°F (20-25°C)
■ avoid excessive heat 40°C (above 104°F)
■ tamper evident sealed packets
■ do not use any opened or torn packets
Inactive Ingredients
carnauba wax, corn starch, fumed silica gel, hypromellose, iron oxide red, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide
Otc - Questions
Questions or comments? 1-800-472-4346
Henry Schein Pdp
NDC #0404-0017-13
Henry Schein®
Ibuprofen
For temporary relief of minor aches and pains associated with headache, toothache, backache, menstrual cramps, common cold, muscular aches, minor arthritis pain and for the reduction of fever.
Henry Schein
Seal Of Excellence®
Ibuprofen 200 mg
(NSAID)
250 Packets/2 Tablets
Reorder
570-0177
* Please review the disclaimer below.