Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL NDC 83324-005-30 QUALITY CHOICE *Compare to the Active Ingredient in Infant's Motrin ® Infants' Ibuprofen Concentrated Drops Pain Reliever/Fever Reducer Oral Suspension, (NSAID) 50 mg Per 1.25 mL For Ages 6 to 23 Months Lasts up to 8 Hours Alcohol Free Dye-Free Use only with enclosed syringe Mixed Berry Flavor 1 fl oz (30 mL) 637-Carton
- PRINCIPAL DISPLAY PANEL NDC 83324-005-30 QUALITY CHOICE *Compare to the Active Ingredient in Infant's Motrin ® Infants' Ibuprofen Concentrated Drops Pain Reliever/Fever Reducer Oral Suspension, (NSAID) 50 mg Per 1.25 mL For Ages 6 to 23 Months Lasts up to 8 Hours Alcohol Free Dye-Free Use only with enclosed syringe Mixed Berry Flavor 1 fl oz (30 mL) 637-Carton
Overview
USE(S) temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Indications & Usage
USE(S) temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
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 below. If possible, use weight to dose; otherwise use age. mL=milliliter measure with dosing device provided. Do not use any other device. dispense liquid slowly into the child's mouth, toward the inner cheek if needed, repeat dose every 6-8 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
Warnings & Precautions
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 you 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.
Purpose
PURPOSE Pain reliever/fever reducer
Do Not Use
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
When Using
WHEN USING THIS PRODUCT take with food or milk if stomach upset occurs
Stop Use & Ask a Doctor
STOP USE AND ASK 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 the 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
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)
Storage & Handling
OTHER INFORMATION store between 20-25 o C (68-77 o F) do not use if carton is opened or if printed neckband is imprinted with "SEALED FOR YOUR PROTECTION" and "USE WITH ENCLOSED DOSING DEVICE ONLY" is broken or missing.
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