DYE-FREE IBUPROFEN- ibuprofen capsule, liquid filled 
CHAIN DRUG MARKETING ASSOCIATION INC.

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QC Ibu mini dye free

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

Warnings

Allergy alert: 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 be fatal. The risk is higher if you use more than directed or for longer 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

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

Ask a doctor or pharmacist before use if you are

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

When using this product

  • take with food or milk if stomach upset occurs

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
  • you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast- feeding,

ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause delivery 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

Other information

Inactive ingredients

gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

Questions or comments?

call toll free 1-888-235-2466

DO NOT USE IF TAMPER-EVIDENT SEAL
UNDER BOTTLE CAP IMPRINTED WITH
“SEALED for YOUR PROTECTION”
IS BROKEN OR MISSING.

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

All trademarks are property of their respective owners. This product is not affiliated

with the owners of Motrin ®IB Liquid Gels.

Distributed by C.D.M.A.,Inc.©

43157 W9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

R0422

L0000581

40's carton

QC®

Quality

Choice

NDC 63868-805-40

†Compare to the active ingredient in

Motrin® IB Liquid Gels

Dye-Free

Ibuprofen

Ibuprofen Capsules, 200 mg

mini capsule

Liquid Filled Softgels

Pain Reliever/Fever Reducer (NSAID)

40 Softgels**

**Liquid Filled Capsules

actual size

carton

DYE-FREE IBUPROFEN 
ibuprofen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-805
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg  in 120 
Inactive Ingredients
Ingredient NameStrength
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code IB5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-805-401 in 1 CARTON11/16/2021
140 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07868211/16/2021
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC. (011920774)
Registrant - Bionpharma Inc. (079637826)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Softgels Inc.002193829manufacture(63868-805)

Revised: 12/2022
Document Id: f0d274bd-b6b5-74c9-e053-2995a90a6f72
Set id: d0eff659-6445-a56a-e053-2995a90a72e9
Version: 2
Effective Time: 20221227
 
CHAIN DRUG MARKETING ASSOCIATION INC.