Direct Safety Ibuprofen

Conney Safety Products, LLC

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purpose
• Direct Safety Ibuprofen Uses
• Warnings
  • 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
• Directions
  • Adults and children: (12 years and older)
  • Children under 12 years:
• Direct Safety Ibuprofen Other information
• Inactive ingredients
• Questions or comments?

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

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

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

• you have problems or serious side effects from taking pain relievers or fever reducers
• stomach bleeding warning applies to you
• you have a history of stomach problems such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you have asthma
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are

• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• under a doctor's care for any serious condition
• taking any other drug

When using this product

• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or longer than directed

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
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• redness or swelling is present in the painful area
• any new or unexpected symptoms occur

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

• do not use more than directed
• the smallest effective dose should be used
• do not take longer than 10 days, unless directed by a doctor (see Warnings)

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:

Do not give to children under 12 years of age.

Other information

• read all product information before using
• store at 68-77°F (20-25°C)
• avoid excessive heat 40°C (above 104°F)
• tamper evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

carnauba wax*, cellulose*, colloidal silicon dioxide*, corn starch*, croscarmellose sodium*, hypromellose*, iron oxide red*, lactose*, magnesium stearate, microcrystalline cellulose, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone*, pregelatinized starch*, silica*, sodium lauryl sulfate*, sodium starch glycolate*, stearic acid*, talc*, titanium dioxide, triacetate*, triacetin*

*may contain

Questions or comments?

1-800-356-9100

100R Direct Safety Ibuprofen Label

Direct Safety®

Ibuprofen

Pain Reliever/Fever Reducer

Ibuprofen 200 mg. (NSAID)

Ibuprofeno 200 mg. (AINE)

Lightly Coated

Industrial Pack 500

(250 Packets of 2 Tablets)