Active Ingredient (In Each 5Ml)
Acetaminophen, 160mg
Childrens Pain And Fever
FDA Label NDC 73282-2016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Calmco Llc for the product Childrens Pain And Fever (NDC 73282-2016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5ml), purpose, uses, warnings, keep out of reach of children, do not use, directions, dosing chart, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
Temporarily: • reduces fever
• relieves minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache
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
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) |
Other Information
- each Single-Use vial contains 8mg of sodium
- store at 68-77°F (20-25°C)
- tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken
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.
Questions Or Comments?
+1 941-202-3270 or visit www.DrKids.com
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