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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson Medical-surgical for the product Mckesson Ibuprofen 200 Mg (NDC 68599-8051). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active ingredient
Ibuprofen 200 mg (NSAID*).
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/fever reducer
Uses
Temporarily relieves minor aches and pains associated with
■ headache ■ toothache ■ backache ■ menstrual cramps
■ common cold ■ muscular aches ■ minor arthritis pain
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
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
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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
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:
Ask a doctor.
Other information
■ read all product information before using
■ store at 68-77°F (20-25°C)
■ avoid excessive heat 104°F (above 40°C)
■ tamper evident sealed packets
■ do not use any opened or torn packets
Inactive ingredients
colloidal silicon dioxide, corn starch, iron oxide red, polyethylene glycol, polyvinyl alcohol,
povidone (K-30), sodium starch glycolate, stearic acid, talc, titanium dioxide
Questions or comments? 1-800-777-4908
NDC 68599-8051-4
This Package id for Househoilds without Young Children
McKesson
Ibuprofen
200 mg
Pain Reliever | Fever Reducer | (NSAID)
2 Per Pack | 200 Packs Per Box
MFR# 543-24805
* Please review the disclaimer below.