Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 73282-2016 | ||||
|---|---|---|---|---|---|
| Drug Name | Childrens pain and fever |
||||
| Type | Brand | ||||
| Active Ingredients |
|
||||
| Route | ORAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 307675 | ||||
| Application Number | part343 | ||||
| Labeler Name | CalmCo LLC | ||||
| Packages |
|
||||
| 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 (5 mL) 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)
| under 24 lbs | under 2 years | Talk to a doctor |
| 24 -35 lbs | 2 - 3 years | 1 Single-Use Vial (5 mL) |
| 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 dihydrate, 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 and Fever Acetaminophen 160mg/5mL TRISODIUM CITRATE DIHYDRATE SODIUM METABISULFITE CITRIC ACID MONOHYDRATE SORBITOL GLYCERIN PROPYLENE GLYCOL MALTITOL XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN WATER EDETATE DISODIUM POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM BENZOATE SUCRALOSE
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 pack
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 (5 mL) 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)
| under 24 lbs | under 2 years | Talk to a doctor |
| 24 -35 lbs | 2 - 3 years | 1 Single-Use Vial (5 mL) |
| 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
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. 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 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. 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
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