CONCENTRATED IBUPROFEN INFANTS - ibuprofen suspension/ drops 
Guardian Drug Company

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Guardian Concentrated Ibuprofen Infants Drops 

ACTIVE INGREDIENT (in each 1.25 mL)

Ibuprofen, USP 50 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 you 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 (mos) DOSE (mL) 
 under 6 mos
 
 ask a doctor
12-17 lbs 6-11 mos 1.25 mL
 18-23 lbs 12-23 years 1.875 mL



OTHER INFORMATION

INACTIVE INGREDIENTS

anhydrous citric acid, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

QUESTIONS OR COMMENTS?

call 1-609-860-2600 (Monday - Friday 8 am - 4 pm)

PRINCIPAL DISPLAY PANEL

NDC 53041-637-09
See New Warnings

For Ages 6 mos. to 23 mos.
Concentrated Infants' Drops
IBUPROFEN
Oral Suspension
50 mg per 1.25 mL
Pain Reliever/Fever Reducer
(NSAID)

Lasts up to 8 Hours
Dye-Free


Berry Flavor
1 fl oz (30 mL)
GUARDIAN


637-GDC-1


CONCENTRATED IBUPROFEN INFANTS 
ibuprofen suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-637
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN50 mg  in 1.25 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRY (Mixed Berry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53041-637-091 in 1 CARTON10/03/2018
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21075510/03/2018
Labeler - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(53041-637)

Revised: 11/2022
Document Id: d0465832-f323-4ecd-a285-33a8c15eb799
Set id: 3a32f0c7-c03e-4783-a429-08280993ddfb
Version: 2
Effective Time: 20221128
 
Guardian Drug Company