CHILDRENS IBUPROFEN - ibuprofen suspension/ drops 
Chain Drug Marketing Association Inc.

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Quality Choice Children's Ibuprofen Oral Suspension 634

ACTIVE INGREDIENT (in each 5 mL)

Ibuprofen, USP 100 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USE(S)

temporarily:


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 your child:



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.

Sore throat warning:
Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

DO NOT USE

ASK A DOCTOR BEFORE USE IF

ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS

WHEN USING THIS PRODUCT

STOP USE AND ASK DOCTOR IF

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DIRECTIONS


Dosing Chart


Weight (lb) Age (yr) Dose (mL)* 
 under 24 under 2 years ask a doctor
 24-35 lbs 2-3 years 5 mL
 36-47 lbs 4-5 years 7.5 mL
 48-59 lbs 6-8 years 10 mL
 60-71 lbs 9-10 years 12.5 mL
 72-95 lbs 11 years 15 mL

*or as directed by a doctor



OTHER INFORMATION

INACTIVE INGREDIENTS

anhydrous citric acid, D&C yellow no. 10, FD&C red no. 40, flavor, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum.

PRINCIPAL DISPLAY PANEL

NDC83324-012-04

QUALITY CHOICE

*Compare to the Active Ingredient in Children's Motrin®
Children's Ibuprofen

Pain Reliever/Fever Reducer
Oral Suspension, USP (NSAID)
100 mg per 5 mL

For Ages 2 to 11 years

Lasts up to 8 Hours

Alcohol Free


Mixed Berry Flavor
4 FL OZ (120 mL)

QC-634-Label

QC-634-Carton

CHILDRENS IBUPROFEN 
ibuprofen suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorBERRY (Mixed Berry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83324-012-041 in 1 CARTON10/25/2023
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21014910/25/2023
Labeler - Chain Drug Marketing Association Inc. (011920774)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(83324-012)

Revised: 10/2023
Document Id: ba0baba6-a7f9-4e4c-88f7-c7fbecc61f25
Set id: ba0baba6-a7f9-4e4c-88f7-c7fbecc61f25
Version: 1
Effective Time: 20231025
 
Chain Drug Marketing Association Inc.