Label: CHILDRENS IBUPROFEN- ibuprofen suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 76413-344-01 - Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 0472-1255
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 8, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- 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:
- hives
- shock
- asthma (wheezing)
- rash
- skin reddening
- blisters
- facial swelling
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
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ASK 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 DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
- WHEN USING THIS PRODUCT
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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 the 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
- KEEP OUT OF REACH OF CHILDREN
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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. If possible, use weight to dose; otherwise use age.
- use only enclosed measuring cup
- if needed, repeat dose every 6-8 hours
- do not use more than 4 times a day
- replace original bottle cap to maintain child resistance
Dosing Chart Weight (lb) Age (yr) Dose (tsp or mL) under 2 years ask a doctor 24 – 35 lbs 2 – 3 years 1 tsp or 5 mL 36 – 47 lbs 4 – 5 years 1½ tsp or 7.5 mL 48 – 59 lbs 6 – 8 years 2 tsp or 10 mL 60 – 71 lbs 9 – 10 years 2½ tsp or 12.5 mL 72 – 95 lbs 11 years 3 tsp or 15 mL Other information
- each teaspoon contains: sodium 2 mg
- do not use if printed neckband is broken or missing
- store between 20 - 25°C (68 - 77°F)
- see bottom panel for lot number and expiration date
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INACTIVE INGREDIENT
Berry flavor: citric acid, D&C yellow #10, FD&C red #40, flavors, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum
Dye free berry flavor: citric acid, flavors, glycerin, hypromellose, polysorbate-80, purified water, sodium benzoate, sucrose, xanthan gum
Bubble gum flavor: artificial bubble gum flavor, citric acid, FD&C red #40, glycerin, hypromellose, polysorbate 80, purified water, sodium benzoate, sucrose, xanthan gum.
- QUESTIONS?
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PRINCIPAL DISPLAY PANEL - 100 MG/5 ML Bottle Label
Austin/Travis Co. Health & Human Services Dept.
1000 Toyath St Austin, TX 78702 512-972-6206IBUPROFEN
100MG/5ML
SUSP.Date:
Name:
Dr.TAKE ___ ML BY MOUTH ___ TIMES A DAY.
05/2018
L606011
IBUPROFEN 100MG/5ML ORAL SUSP. #120 NDC 76413-344-01
Batch: 08301708
Lot: L606011
Exp: 05/2018
ACTAVISFederal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
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INGREDIENTS AND APPEARANCE
CHILDRENS IBUPROFEN
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-344(NDC:0472-1255) 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color ORANGE (red) Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-344-01 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074916 06/01/2006 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 REPACK(76413-344) , RELABEL(76413-344)