Otc - Active Ingredient
Active ingredient (in each capsule)
Solubilized Ibuprofen equal to
200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
* nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Laboratories, Inc. for the product Ibuprofen (NDC 49483-133). 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.
Active ingredient (in each capsule)
Solubilized Ibuprofen equal to
200 mg ibuprofen (NSAID)*
(present as the free acid and potassium salt)
* nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/Fever reducer
Uses
headache
toothache
backache
menstrual cramps
the common cold
muscular aches
minor pain of arthritis
Warnings
Allergy alerts: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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:
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
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better
chest pain
trouble breathing
weakness in one part or side of body
slurred speech
leg swelling
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 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.
Directions
if pain or fever does not respond to 1 capsule, 2 capsules may be used
do not exceed 6 capsules in 24 hours, unless directed by a doctor
other information
Inactive ingredients Ammonia, FD&C green no 3, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, propylene glycol, potassium hydroxide, water, shellac, sorbitan monooleate, sorbitol sorbitan
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* Please review the disclaimer below.