Active Ingredient
Acetaminophen 160mg
Sanar Naturals Childrens Pain Reliever
FDA Label NDC 73386-324
13 label sections · Submitted to the FDA by Sanvall Enterprises, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sanvall Enterprises, Inc. for the product Sanar Naturals Childrens Pain Reliever (NDC 73386-324). 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, purpose, uses, warnings, do not use, ask a doctor, ask a doctor or pharmacist before use, otc - when using, 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
- 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 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
your child has liver disease.
Ask A Doctor Or Pharmacist Before Use
your child is taking the blood thinning drug warfarin.
Otc - When Using
When using this product do not exceed recommended dose
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
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)
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
This product does not contain directions or complete warnings for adult use. Do not give more than directed (see overdose warning). Shake well before using. ml=milliliter. Find right dose on chart below. If possible, use weight to dose; otherwise, use age.
Remove the child protective cap and squeeze your child's dose into the dosing cup. Repeat dose every 4 hours while symptoms last, do not give more than 5 times in 24 hours.
| Weight (lb) | Age (yr) | Dose (ml)* |
| under 24 | under 2 years | 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 |
*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.
Inactive Ingredients
Flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium carboxymethylcellulose and sucralose.
Other Information
www.sanarnaturals.com
* Please review the disclaimer below.
