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| Product NDC Code | 55154-5787 | ||||
|---|---|---|---|---|---|
| Drug Name | Childrens acetaminophen |
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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 | Cardinal Health 107, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 5 mL) 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 • do not take more than directed (see overdose warning ) • shake well before using • mL = milliliter • find the right dose on chart below. If possible, use weight to dose; otherwise, use age • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours Weight (lbs) Age (yr) Dose (mL) or as directed by a doctor Under 24 Under 2 Ask a doctor 24-35 2-3 years 5 mL 36-47 4-5 years 7.5 mL 48-59 6-8 years 10 mL 60-71 9-10 years 12.5 mL 72-95 11 years 15 mL
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acesulfame K, butylparaben, citric acid, FD&C Red No. 40, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and 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 pain 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 Acetaminophen Acetaminophen ACESULFAME POTASSIUM BUTYLPARABEN CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL MAGNESIUM ALUMINUM SILICATE XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN
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.PRINCIPAL DISPLAY PANEL - 5 mL Cup Children’s Acetaminophen Oral Suspension 160 mg per 5 mL 5 Unit-Dose Cups Bag Label
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
MANUFACTURED BY Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com Distributed By: Cardinal Health Dublin, OH 43017 L55345731223 R09/20
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 the reach of children . Overdose warning : 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 children even if you do not notice any sign or symptoms
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 1-800-845-8210.
Storage and handling
Information about safe storage and handling of the drug product.Other information • each 5 mL contains: sodium 2 mg • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • protect from freezing • a red, berry flavored suspension supplied in the following oral dosage form: Overbagged with 5 Unit-Dose Cups per bag, NDC 55154-5787-5
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 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 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 of the inactive ingredients in this product. Ask a doctor before use if your child has liver disease. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. When using this product, do not exceed the recommended dose (see overdose warning) 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.
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