Label: IBUPROFEN INFANTS- ibuprofen suspension/ drops
- NDC Code(s): 51672-2146-3
- Packager: Taro Pharmaceuticals U.S.A., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 1.25 mL)
- Purposes
- Uses
-
Warnings
Allergy alert
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- 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 your child:
- has had stomach ulcers or bleeding problems
- takes a blood thinning (anticoagulant) or steroid drug
- takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- takes more or for a longer time than directed
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
- if the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if
- stomach bleeding warning applies to your child
- child has a history of stomach problems, such as heartburn
- child has problems or serious side effects from taking pain relievers or fever reducers
- child has not been drinking fluids
- child has lost a lot of fluid due to vomiting or diarrhea
- child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
- child has asthma
- child is taking a diuretic
Ask a doctor or pharmacist before use if the child is
- under a doctor's care for any serious condition
- taking any other drug
Stop use and ask a doctor if
- child experiences any of the following signs of stomach bleeding:
- feels faint
- vomits blood
- has bloody or black stools
- has stomach pain that does not get better
- child has symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
- the child does not get any relief within first day (24 hours) of treatment
- fever or pain gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
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Directions
- this product does not contain directions or complete warnings for adult use
- do not give more than directed
- shake well before using
- find right dose on chart below. If possible, use weight to dose; otherwise use age.
- mL = milliliter
- measure with the dosing device provided. Do not use with any other device.
- dispense liquid slowly into the child's mouth, toward the inner cheek
- if needed, repeat dose every 6 to 8 hours
- do not use more than 4 times a day
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 mos 1.875 mL - Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
*Compare to the active
ingredient in
Motrin® Infants' DropsNDC 51672-2146-3
For Ages 6 Mos. to 23 Mos.
Concentrated
Infants' Drops
IbuprofenOral Suspension (NSAID)
50 mg per 1.25 mL
Pain reliever / Fever reducerDye-Free
Alcohol FreeUse only with
enclosed
syringe.Lasts
up to
8 hoursBerry Flavor
1 FL OZ (30 mL)
-
INGREDIENTS AND APPEARANCE
IBUPROFEN INFANTS
ibuprofen suspension/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2146 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 50 mg in 1.25 mL Inactive Ingredients Ingredient Name Strength CARAMEL (UNII: T9D99G2B1R) SORBITOL SOLUTION (UNII: 8KW3E207O2) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (White-to-off-white) Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-2146-3 1 in 1 CARTON 08/08/2023 1 30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217261 08/08/2023 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-2146)