KOSHER MEDS- ibuprofen suspension 
Mollec Inc

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KOSHER-MEDS Children's Ibuprofen

Active Ingredient

Ibuprofen 100mg (NSAID)

Purpose

Pain Reliever/Fever Reducer

Uses

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

take with food or milk if stomach upset occurs

Stop use and ask a 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 24under 2 yearsask a doctor
24-35 lbs2-3 years5 mL
36-47 lbs4-5 years7.5 mL
48-59 lbs6-8 years

10 mL

60-71 lbs9-10 years12.5 mL
72-95 lbs11 years

15 mL

*or as directed by a doctor

Inactive ingredients

Acesulfame potassium, anhydrous ctiric acid, carboxylmethylcellulose sodium, D&C Yellow #10, FD&C Red #40, flavors, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sucrose, and xanthan gum

Questions or comments?

Call 1-732-314-4550 from 9 AM to 5 PM EST, Monday-Friday.

Product label

image descriptionimage description

KOSHER MEDS 
ibuprofen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82179-001
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)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SUCROSE (UNII: C151H8M554)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82179-001-041 in 1 BOX08/17/2021
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21060208/17/2021
Labeler - Mollec Inc (040088196)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(82179-001)

Revised: 11/2023
Document Id: 09a996e1-cfb7-fc86-e063-6294a90ab24c
Set id: c9c31326-6a19-9a9c-e053-2a95a90aed06
Version: 4
Effective Time: 20231108
 
Mollec Inc