Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN GLYCERIN POLYSORBATE 80 SODIUM BENZOATE SUCROSE XANTHAN GUM WATER NONCRYSTALLIZING SORBITOL SOLUTION CITRIC ACID MONOHYDRATE CELLULOSE, MICROCRYSTALLINE CARBOXYMETHYLCELLULOSE SODIUM EDETATE DISODIUM PROPYLENE GLYCOL off-white
Drug Facts
Composition & Profile
Identifiers & Packaging
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL See New Warnings NDC 59556-149-01 For Ages 6-23 Months Ibuprofen Concentrated Drops Oral Suspension 50 mg per 5 mL Pain Reliever / Fever Reducer (NSAID) Lasts up to 8 hours Alcohol Free Mix Berry Flavor 1/2 fl oz (15 mL) See New Warnings NDC 59556-149-02 For Ages 6-23 Months Ibuprofen Concentrated Drops Oral Suspension 50 mg per 5 mL Pain Reliever / Fever Reducer (NSAID) Lasts up to 8 hours Alcohol Free Mix Berry Flavor 1 fl oz (30 mL) 15 mL carton label 30 mL carton label
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL See New Warnings NDC 59556-149-01 For Ages 6-23 Months Ibuprofen Concentrated Drops Oral Suspension 50 mg per 5 mL Pain Reliever / Fever Reducer (NSAID) Lasts up to 8 hours Alcohol Free Mix Berry Flavor 1/2 fl oz (15 mL) See New Warnings NDC 59556-149-02 For Ages 6-23 Months Ibuprofen Concentrated Drops Oral Suspension 50 mg per 5 mL Pain Reliever / Fever Reducer (NSAID) Lasts up to 8 hours Alcohol Free Mix Berry Flavor 1 fl oz (30 mL) 15 mL carton label 30 mL carton label
Overview
Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, headache and toothaches
Indications & Usage
Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, headache 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. If possible, use weight to dose; otherwise use age. repeat dose every 6-8 hours, if needed do not use more than 4 times a day measure with the dosing device provided. Do not use with any other device. Dosing Chart Weight (lb) Age (mos) Dose (mL) under 6 mos ask a doctor 12-17 lb 6-11 mos 1.25 mL 18-23 lb 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 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 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. 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 problems or serious side effects from taking pain relievers or fever reducers child has a history of stomach problems, such as heartburn child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke child has not been drinking fluids child has lost a lot of fluid due to vomiting or diarrhea 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 take with food or milk if stomach upset occurs 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 child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling 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
Purpose
Purpose Fever reducer/Pain reliever
Keep Out of Reach of Children
OTC - KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away.
Storage & Handling
Other Information one dose lasts 6-8 hours store at 20-25°C (68-77°F) see bottom of box for lot number and expiration date
Questions
Questions or comments? Call Strides Pharma Inc. weekdays from 9 AM to 5 PM EST at 1-877-244-9825 or ask your pharmacist, doctor or health care professional or visit www.strides.com. Manufactured by: Strides Pharma Science Limited Bengaluru - 562106, India. Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816 Revised: 05/2022
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