NDC | 68094-600-59, 68094-600-61, 68094-600-62 |
Set ID | eccee4c6-aa94-468a-aebd-265d7a9efb6d |
Category | HUMAN OTC DRUG LABEL |
Packager | Precision Dose Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA074937 |
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL = 1 teaspoonful)
- 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
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 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, or kidney disease
- 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
When using this product
- give with food or milk if stomach upset occurs
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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
- 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
-
Directions
- use as directed per healthcare professional
- this product does not contain directions or complete warnings for adult use
- do not give more than directed
- shake well before using
- mL = milliliter; tsp = teaspoonful
- find right dose on chart. If possible, use weight to dose; otherwise use age.
- if needed, repeat dose every 6-8 hours
- do not use more than 4 times a day
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- How Supplied
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 mg/5 mL Cup Label
-
INGREDIENTS AND APPEARANCE
DYE FREE CHILDRENS IBUPROFEN
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-600(NDC:0113-0685) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ibuprofen (UNII: WK2XYI10QM) (Ibuprofen - UNII:WK2XYI10QM) Ibuprofen 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength Anhydrous citric acid (UNII: XF417D3PSL) Glycerin (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) polysorbate 80 (UNII: 6OZP39ZG8H) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) xanthan gum (UNII: TTV12P4NEE) high fructose corn syrup (UNII: XY6UN3QB6S) Product Characteristics Color WHITE Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68094-600-62 3 in 1 CASE 08/26/2015 1 10 in 1 TRAY 1 NDC:68094-600-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:68094-600-61 10 in 1 CASE 08/26/2015 2 10 in 1 TRAY 2 NDC:68094-600-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074937 08/26/2015 Labeler - Precision Dose Inc. (035886746)