Active Ingredient
Ibuprofen 200 mg (NSAID)*
* nonstreoidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Apotheca, Inc for the product Ibuprofen (NDC 12634-518). 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 active ingredient, purpose, warnings, do not use, ask doctor/pharmacist, pregnacncy or breast feeding, keep out of reach of children, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Ibuprofen 200 mg (NSAID)*
* nonstreoidal anti-inflammatory drug
Pain reliever / fever reducer
Use(s)
temporarily relieves minor aches and pain due to :
backache
headache
menstrual cramps
minor pain of arthritis
muscular aches
the common cold
toothache
temporarily reduces fever
Allergy alerts: Ibuprofen may cause a severe allergy 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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask doctor if
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 a problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a PoisonControlCenter right away. (1-800-222-1222)
colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinised starch, talc, titanium dioxide.
Directions
adults and children 12 years and older |
|
Children under 12 years |
|
Other information
store between 20-25 0c (68-77 0 F).
Manufactured for:
Marksans Pharma Inc.
Lake Grove, NY11755, USA
Manufactured by:
Marksans Pharma Ltd.
Verna, Goa-403722, India
Repackaged and Distributed by:
Apotheca, Inc.
Phoenix, AZ 85006
Repackaged and Distributed for:
RejuviLife
Phoenix, AZ 85015
NDC 12634-518-74
IBUPROFEN
MAXIMUM STRENGTH
WITHOUT A PRESCRIPTION
BROWN COATED TABLETS
Pain Reliver
Fever Reducer
RejuviLife®
24 TABLETS 200MG
* Please review the disclaimer below.