Childrens Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN ANHYDROUS CITRIC ACID D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN HYPROMELLOSE 2910 (4000 MPA.S) POLYSORBATE 80 WATER SODIUM BENZOATE SUCROSE XANTHAN GUM ALCOHOL
Drug Facts
Composition & Profile
Identifiers & Packaging
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Compare to the active ingredient in Children’s Motrin® Grape* NDC 0536-1082-97 For ages 2 to 11 CHILDREN’S Ibuprofen Oral Suspension, USP (NSAID) 100 mg per 5 mL (teaspoon) Pain Reliever Fever Reducer Lasts up to 8 hours Grape Flavor Alcohol Free 4 FL OZ (118 mL) C:\Users\charlene.young\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.Outlook\1U3DRAJ6\Rugby - Children's Ibuprofen Oral Susp (Grape) -1082-97 Box 370434 (3-15).jpg
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Compare to the active ingredient in Children’s Motrin® Grape* NDC 0536-1082-97 For ages 2 to 11 CHILDREN’S Ibuprofen Oral Suspension, USP (NSAID) 100 mg per 5 mL (teaspoon) Pain Reliever Fever Reducer Lasts up to 8 hours Grape Flavor Alcohol Free 4 FL OZ (118 mL) C:\Users\charlene.young\AppData\Local\Microsoft\Windows\Temporary Internet Files\Content.Outlook\1U3DRAJ6\Rugby - Children's Ibuprofen Oral Susp (Grape) -1082-97 Box 370434 (3-15).jpg
Overview
USES temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
Indications & Usage
USES temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever
Dosage & Administration
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
Warnings & Precautions
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.
Purpose
PURPOSE Pain reliever/fever reducer
Do Not Use
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
When Using
WHEN USING THIS PRODUCT take 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 & Ask a Doctor
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
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).
Questions
QUESTIONS? 1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday. Generic Section U.S. Patent No. 5,712,310 *This product is not affiliated with, manufactured by, or produced by the makers or owners of Children’s Motrin® 12620112A1 VC112419 Made in USA Distributed By: RUGBY LABORATORIES 31778 Enterprise Drive, Livonia, MI 48150 www.rugbylaboratories.com Rev. 03/15 Re-Order No. 370434 R-46
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