SANAR NATURAL- acetaminophen solution

Sanar Natural by

Drug Labeling and Warnings

Sanar Natural by is a Otc medication manufactured, distributed, or labeled by Evi Labs, Luis Echeverria. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium carboxymethylcellulose and sucralose

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.

Purpose

Pain reliever/Fever reducer

Active Ingredient

Acetaminophen 160 mg

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)

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.

KEEP OUT OF REACH OF CHILDREN

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.

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.

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

Indications & Usage

reduces fever
relieves minor aches and pains due to:
the common cold
flu
headache
sore throat
toothache

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SANAR NATURAL 
acetaminophen solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84178-324
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	175 mg  in 5 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH)	15 mg  in 5 mL
METHYLPARABEN (UNII: A2I8C7HI9T)	20 mg  in 5 mL
WATER (UNII: 059QF0KO0R)	4055.2 mg  in 5 mL
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)	37.5 mg  in 5 mL

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84178-324-01	1 in 1 CARTON	03/30/2024
1		120 mL in 1 BOTTLE, UNIT-DOSE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	03/30/2024

Labeler - Evi Labs (123617598)

Registrant - Luis Echeverria (123617598)

Establishment
Name	Address	ID/FEI	Business Operations
Evi Labs		123617598	manufacture(84178-324)