Otc - Active Ingredient
ACTIVE INGREDIENT(S)
Ibuprofen 200 mg (NSAID)*
* nonstreoidal anti-inflammatory drug
Ibuprofen Ca Tablet, Coated
FDA Label NDC 11673-990
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Ibuprofen Ca (NDC 11673-990). 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, inactive ingredient, otc - purpose, indications & usage, dosage & administration, otc - keep out of reach of children, warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
TALC
TITANIUM DIOXIDE
STARCH, PREGELATINIZED CORN
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOL
Otc - Purpose
PURPOSE
Pain reliever / fever reducer
Indications & Usage
USE(S)
temporarily relieves minor aches and pains due to :
backache
headache
menstrual cramps
minor pain of arthritis
muscular aches
the common cold
toothache
temporarily reduces fever
Dosage & Administration
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 1caplet, 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
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. (1-800-222-1222)
Warnings
WARNINGS
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
asthma (wheezing)
blisters
facial swelling
hives
rash
shock
skin reddening
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 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: NSAID's except aspirin increases the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or longer than directed.
Package Label.Principal Display Panel
* Please review the disclaimer below.
