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| Product NDC Code | 73282-1164 | ||||
|---|---|---|---|---|---|
| Drug Name | Childrens pain and fever |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 307675 | ||||
| Application Number | part343 | ||||
| Labeler Name | CalmCo 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.Active Ingredient (in each 5ml) Acetaminophen, 160mg
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.Dosing Chart Weight (lbs) Age (Years Dose (mL) under 24 lbs under 2 years Talk to a doctor 24-35 lbs 2-3 years 1 Single-Use Vial (5mL) 36-47 lbs 4-5 years Talk to a doctor 48-71 lbs 6-10 years 2 Single-Use Vial (10 mL) 72-95 lbs 11 years 3 Single-Use Vial (15 mL)
| Weight (lbs) | Age (Years | Dose (mL) |
| under 24 lbs | under 2 years | Talk to a doctor |
| 24-35 lbs | 2-3 years | 1 Single-Use Vial (5mL) |
| 36-47 lbs | 4-5 years | Talk to a doctor |
| 48-71 lbs | 6-10 years | 2 Single-Use Vial (10 mL) |
| 72-95 lbs | 11 years | 3 Single-Use Vial (15 mL) |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients citric acid, cherry flavor, edetate disodium, glycerin, maltitol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose. trisodium citrate dihyrate, 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 Uses Temporarily: • reduces fever • relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache
Spl product data elements
Usually a list of ingredients in a drug product.Childrens Pain and Fever Acetaminophen ACETAMINOPHEN ACETAMINOPHEN SODIUM METABISULFITE TRISODIUM CITRATE DIHYDRATE GLYCERIN CITRIC ACID MONOHYDRATE MALTITOL POLYETHYLENE GLYCOL, UNSPECIFIED XANTHAN GUM WATER SORBITOL PROPYLENE GLYCOL SUCRALOSE EDETATE DISODIUM SODIUM BENZOATE
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 Art File- 4ct Carton Package Art File- 4ct Carton package art file
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
Ask a doctor before use if your child has liver disease
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 of the inactive ingredients in this product
Instructions for use
Information about safe handling and use of the drug product.Directions • this product does not contain directions or complete warnings for adult use. • do not give more than directed (see overdose warning) • use the chart below to confirm dose. If possible, use weight to confirm, otherwise use age • give the recommended number of vials below following the instructions under "Easy to Use" on the side panel. • empty each Single-Use Vial required of all liquid when dosing • 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 Dosing Chart Weight (lbs) Age (Years Dose (mL) under 24 lbs under 2 years Talk to a doctor 24-35 lbs 2-3 years 1 Single-Use Vial (5mL) 36-47 lbs 4-5 years Talk to a doctor 48-71 lbs 6-10 years 2 Single-Use Vial (10 mL) 72-95 lbs 11 years 3 Single-Use Vial (15 mL)
| Weight (lbs) | Age (Years | Dose (mL) |
| under 24 lbs | under 2 years | Talk to a doctor |
| 24-35 lbs | 2-3 years | 1 Single-Use Vial (5mL) |
| 36-47 lbs | 4-5 years | Talk to a doctor |
| 48-71 lbs | 6-10 years | 2 Single-Use Vial (10 mL) |
| 72-95 lbs | 11 years | 3 Single-Use Vial (15 mL) |
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). Prompt medical attention is critical even if you do not notice any signs or symptoms.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information each Single-Use vial contains 8mg of sodium store at 68-77ºF (20-25ºC) tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken
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? +1 941-202-3270 or visit www.DrKids.com
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.
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 for this product • 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. 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). Prompt medical attention is critical even if you do not notice any signs or symptoms. 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 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. Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin Ask a doctor before use if your child has liver disease
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