Otc - Active Ingredient
Ibuprofen 200 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Cabinet Health P.b.c. for the product Goodmeds Ibuprofen 200mg (NDC 82725-4029). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen 200 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
Pain reliever/Fever reducer
Uses
temporarily relieves minor aches and pains due to:
headache
toothache
backache
menstrual cramps
the common cold
muscular aches
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
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 a nonsteroidal
anti-inflammatory drug (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
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
the 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 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
When using this product
take with food or milk if stomach upset occurs
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
If pregnant or breast-feeding, ask a health professional before
use. It is especially important not to use ibuprofen at 20 weeks
or later in pregnancy unless definitely directed to do so by a
doctor because it may cause problems in the unborn child
or complications during delivery.
Keep out of reach of children. In case of overdose,
get medical help or contact a Poison Control Center
right away. (1-800-222-1222)
Directions
do not take more than directed
the smallest effective dose should be used
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, unless
directed by a doctor
children under 12 years: ask a doctor
Other information
read all warnings and directions before use.
store between 20 ̊–25 ̊C (68 ̊–77 ̊F)
avoid excessive heat above 40°C (104°F)
Inactive ingredients colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide, triacetin.
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