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| Product NDC Code | 58602-227 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Infants ibuprofen |
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| Type | Brand | ||||||
| Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | SUSPENSION | ||||||
| RxCUI drug identifier | 204442 | ||||||
| Application Number | ANDA213506 | ||||||
| Labeler Name | Aurohealth LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient (in each 1.25 mL) Ibuprofen USP 50 mg (NSAID) * * nonsteroidal anti-inflammatory drug
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 the dosing device provided. Do not use with any other device. dispense liquid slowly into the child's mouth, toward the inner cheek if needed, repeat dose every 6 to 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 to 17 lbs 6 to 11 mos 1.25 mL 18 to 23 lbs 12 to 23 mos 1.875 mL Other information store between 20° to 25°C (68° to 77°F) do not use if carton is opened or seal under cap is broken or missing
| under 6 mos | ask a doctor | |
| 12 to 17 lbs | 6 to 11 mos | 1.25 mL |
| 18 to 23 lbs | 12 to 23 mos | 1.875 mL |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acesulfame potassium, art raspberry flavor (contains propylene glycol), citric acid anhydrous, FD&C Red No. 40, glycerin, hypromellose, noncrystallizing sorbitol solution, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose, xanthan gum
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.Infants Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN ACESULFAME POTASSIUM PROPYLENE GLYCOL ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN HYPROMELLOSE 2208 (4000 MPA.S) NONCRYSTALLIZING SORBITOL SOLUTION POLYSORBATE 80 STARCH, POTATO WATER SODIUM BENZOATE SUCROSE XANTHAN GUM Light Pink to Pink
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Container Label AUROHEALTH NDC 58602-227-07 For Ages 6 Mos. to 23 Mos. Concentrated Infants' Drops Ibuprofen Oral Suspension, USP (NSAID) 50 mg per 1.25 mL Pain Reliever/Fever Reducer (NSAID) Concentrated Drops Lasts up to 8 hours Use only with enclosed syringe. Berry Flavor 1 fl oz (30 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Container Label
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Container Carton Label AUROHEALTH NDC 58602-227-07 # Compare to the active ingredient in Motrin ® Infants' Drops See New Warnings For Ages 6 Mos. to 23 Mos. Concentrated Infants ' Drops Ibuprofen Oral Suspension, USP (NSAID) 50 mg per 1.25 mL Pain Reliever/ Fever Reducer (NSAID) Concentrated Drops Lasts up to 8 hours Use only with enclosed syringe. Berry Flavor 1 fl oz (30 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 FL OZ (30 mL) Carton Label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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, kidney disease, or had a stroke child has asthma child is taking a diuretic
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if the child is under a doctor's care for any serious condition taking any other drug
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/19/1993
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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 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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product take with food or milk if stomach upset occurs
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API