Label: INFANTS IBUPROFEN- ibuprofen suspension
- NDC Code(s): 71205-110-15, 71205-110-30
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 45963-125
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 1, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each 1.25 mL)
- Purpose
- Uses
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Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- 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:
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- has had stomach ulcers or bleeding problems
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- takes a blood thinning (anticoagulant) or steroid drug
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- takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- 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
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- if the child has ever had an allergic reaction to any other pain reliever/fever reducer
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- right before or after heart surgery
Ask a doctor before use if
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- stomach bleeding warning applies to your child
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- child has a history of stomach problems, such as heartburn
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- child has problems or serious side effects from taking pain relievers or fever reducers
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- child has not been drinking fluids
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- child has lost a lot of fluid due to vomiting or diarrhea
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- child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
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- child has asthma
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- child is taking a diuretic
Ask a doctor or pharmacist before use if the child is
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- under a doctor's care for any serious condition
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- taking any other drug
Stop use and ask a doctor if
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- side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
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- child experiences any of the following signs of stomach bleeding:
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- feels faint
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- vomits blood
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- has bloody or black stools
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- has stomach pain that does not get better
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- child has symptoms of heart problems or stroke:
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- chest pain
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- trouble breathing
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- weakness in one part or side of body
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- slurred speech
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- leg swelling
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- the child does not get any relief within first day (24 hours) of treatment
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- fever or pain gets worse or lasts more than 3 days
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- redness or swelling is present in the painful area
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- any new symptoms appear
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Directions
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- this product does not contain directions or complete warnings for adult use
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- do not give more than directed
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- shake well before using
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- find right dose on chart below. If possible, use weight to dose; otherwise use age.
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- mL = milliliter
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- measure with the dosing device provided. Do not use with any other device.
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- dispense liquid slowly into the child's mouth, toward the inner cheek
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- if needed, repeat dose every 6 to 8 hours
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- do not use more than 4 times a day
Dosing Chart
Weight (lb)
Age (mos)
Dose (mL)
under 6 mos
ask a doctor
12 to 17 lbs
6 to 11 mos
1.25 mL
18 to 23 lbs
12 to 23 mos
1.875 mL
- Other information
- Inactive ingredients
- Questions or Comments?
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Principal Display Panel
Actavis
Compare to the active ingredient in Concentrated Motrin® Infants’ Drops†
NDC 71205-110-30
See New Warnings
For Ages 6 Mos. to 23 Mos.
Infants’ Ibuprofen
Concentrated Ibuprofen Oral Suspension, USP
(NSAID)
50 mg per 1.25 mL
Pain Reliever
Fever Reducer
Lasts up to 8 hours
Non-Staining
Use only with enclosed syringe
Dye-Free Berry Flavor
Alcohol Free
½ FL OZ (15 mL)
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
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INGREDIENTS AND APPEARANCE
INFANTS IBUPROFEN
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-110(NDC:45963-125) 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 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Other Ingredients Ingredient Kind Ingredient Name Quantity Does not contain ALCOHOL (UNII: 3K9958V90M) 0 in 1.25 mL 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:71205-110-15 1 in 1 CARTON 09/03/2018 1 15 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 2 NDC:71205-110-30 1 in 1 CARTON 09/03/2018 2 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 ANDA079058 05/11/2010 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(71205-110)
