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| Product NDC Code | 83474-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Childrens pain relief and fever reducer oral suspension cherry |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SUSPENSION | ||||
| RxCUI drug identifier | 307668 | ||||
| Application Number | M013 | ||||
| Labeler Name | Puro Pharma Inc. | ||||
| Packages |
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Overdosage of Childrens Pain Relief and Fever Reducer Oral Suspension Cherry
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 5 mL = 1 teaspoonful) Acetaminophen 160 mg
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. ■ shake well before using ■ mL = milliliter; tsp = teaspoonful ■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age. ■ if needed, repeat dose every 4 hours while symptoms last ■ do not give more than 5 times in 24 hours ■ do not give for more than 5 days unless directed by a doctor. Weight (lb) Age (yr) Dose (mL or tsp)* under 24 under 2 years ask a doctor 24-35 2 - 3 years 5 mL (1 tsp) 36-47 4 - 5 years 7.5 mL (1 1/2 tsp) 48-59 6 - 8 years 10 mL (2 tsp) 60-71 9 - 10 years 12.5. mL (2 1/2 tsp) 72-95 11 years 15 mL (3 tsp) * or as directed by a doctor Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
| Weight (lb) | Age (yr) | Dose (mL or tsp)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2 - 3 years | 5 mL (1 tsp) |
| 36-47 | 4 - 5 years | 7.5 mL (1 1/2 tsp) |
| 48-59 | 6 - 8 years | 10 mL (2 tsp) |
| 60-71 | 9 - 10 years | 12.5. mL (2 1/2 tsp) |
| 72-95 | 11 years | 15 mL (3 tsp) |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, butylparaben, FD&C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, 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 ■ headache ■ sore throat ■ toothache
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.Childrens Pain Relief and Fever Reducer Oral Suspension Cherry ACETAMINOPHEN ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID BUTYLPARABEN FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP CELLULOSE, MICROCRYSTALLINE CARBOXYMETHYLCELLULOSE SODIUM PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION SUCRALOSE XANTHAN GUM
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 Labeling PURO PHARMA Children's Pain & Fever Acetaminophen Oral Suspension Cherry Flavor PURO PHARMA NDC 83474-001-04 COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S TYLENOL ORAL SUSPENSION* PURO PHARMA Children's Pain & Fever Acetaminophen Oral Suspension Pain reliever Fever Reducer • Ibuprofen Free • Aspirin Free • For Ages 2 to 11 4 FL OZ (118 mL) 160 mg per 5 mL Cherry Flavor This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol ® Oral Suspensin Distributed by: Puro Pharma Inc. 42 Catharine St. Poughkeepsie, NY 12601 [email protected] BX-175 res 001-04 Cherry Box 001-04 Bottl Cherry
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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 your child has liver disease.
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 your child is taking the blood thinning drug warfarin.
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 ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ If your child is allergic to acetaminophen or any other of the inactive ingredients in this product.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ each 5 mL (1 tsp) contains; sodium 3 mg ■ store between 20-25ºC (68-77ºF) ■ do not refrigerate ■ Keep carton for full directions for use.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-877-798-5944
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 ■ pain gets worse or lasts more than 5 days ■ fever gets worse or lasts more than 3 days ■ new symptoms occur ■ redness or swelling is present. These could be signs of a serious condition.
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 do not exceed recommended dose (see overdose warning)
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 Liver warning This product contains acetaminophen. Severe liver damage may occur if your child takes: ■ more than 5 doses in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
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