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| Product NDC Code | 84178-324 | ||||
|---|---|---|---|---|---|
| Drug Name | Sanar natural |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | BUCCAL | ||||
| Dosage Form | SOLUTION | ||||
| Application Number | M013 | ||||
| Labeler Name | Evi Labs | ||||
| 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 Acetaminophen 160 mg
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 75-95 lbs 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.
| Weight(lb) | Age (yr) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 lbs | 2-3 years | 5 mL |
| 36-47 lbs | 4-5 years | 7.5 mL |
| 48-59 lbs | 6-8 years | 10 mL |
| 60-71 lbs | 9-10 years | 12.5 mL |
| 75-95 lbs | 11 years | 15 mL |
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.Dosage & Administration 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 doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 75-95 lbs 11 years 15 mL *or as directed by a doctor
| Weight (lb) | Age (yr) | Dose (mL) |
| under 24 | under 2 years | ask doctor |
| 24-35 lbs | 2-3 years | 5 mL |
| 36-47 lbs | 4-5 years | 7.5 mL |
| 48-59 lbs | 6-8 years | 10 mL |
| 60-71 lbs | 9-10 years | 12.5 mL |
| 75-95 lbs | 11 years | 15 mL |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium carboxymethylcellulose and sucralose
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.Indications & Usage 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.Sanar Natural Acetaminophen GLYCERIN PROPYLPARABEN METHYLPARABEN WATER CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 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.imagen
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 Do not use with any other drug containing acetaminophen(prescription or no prescription). 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 recommended dose (see overdose warning)
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 Overdose warning: in case overdose, get medical help or contact a Paison 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.
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 Stop use and ask a doctor if: pain gets worse or lasts more then 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 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.
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