RAPID COMFORT IBUPROFEN- ibuprofen tablet, film coated 
Lab Safety Supply, Inc.

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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? 1-800-356-0783

Label Safety Ibuprofen Label 60683-083

Lab Safety Ibuprofen Label 60683-083

Rapid Comfort ™

Ibuprofen

200 mg USP (NSAID)

Easy To Swallow Film-Coated Tablets

Facil de Tragar

Tabletas con Capa Ultradelgada

Compare active ingredient to:

Advil®

Registered Trademark of Pfizer Consumer Healthcare

Pull to Open

500 Tablets (250 x 2s)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias

rap04-0000-01-2 Lab Safety Label 60683-083

Lab Safety Ibuprofen Label 60683-082

rap04-0000-01-2 Lab Safety Label 60683-082Lab Safety Ibuprofen Label 60683-082

Rapid Comfort ™

Ibuprofen

200 mg USP (NSAID)

Easy To Swallow Film-Coated Tablets

Facil de Tragar

Tabletas con Capa Ultradelgada

Compare active ingredient to:

Advil®

Registered Trademark of Pfizer Consumer Healthcare

Pull to Open

500 Tablets (250 x 2s)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias

RAPID COMFORT IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:60683-083
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
SILICON DIOXIDE 
STARCH, CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code 115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60683-083-13250 in 1 BOX, UNIT-DOSE
12 in 1 PACKET
2NDC:60683-083-3350 in 1 BOX, UNIT-DOSE
22 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123710/11/201211/01/2013
RAPID COMFORT IBUPROFEN 
ibuprofen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:60683-082
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CELLULOSE, MICROCRYSTALLINE 
FERRIC OXIDE RED 
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POVIDONE 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
Colorbrown (brown) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code IP;140
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60683-082-13250 in 1 BOX, UNIT-DOSE
12 in 1 PACKET
2NDC:60683-082-3350 in 1 BOX, UNIT-DOSE
22 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07133310/11/201208/01/2014
Labeler - Lab Safety Supply, Inc. (042851410)

Revised: 1/2015
 
Lab Safety Supply, Inc.