Sanar Naturals Childrens Pain Reliever

Sanar Naturals Childrens Pain Reliever
SPL v4
SPL
SPL Set ID 0eb36805-563f-3fa1-e063-6294a90ab8e1
Route
ORAL
Published
Effective Date 2024-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Propylparaben Glycerin Methylparaben Propylene Glycol Water Carboxymethylcellulose Sodium, Unspecified Form Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-02-05 Until 2026-06-17

Description

Acetaminophen 160mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160mg

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

Section 50567-7

When using this product do not exceed recommended dose

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.

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.

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.

Active Ingredient

Acetaminophen 160mg

Other Information

www.sanarnaturals.com

Inactive Ingredients

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

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.

Ask A Doctor Or Pharmacist Before Use

your child is taking the blood thinning drug warfarin.

Sanar Naturals Children's Pain + Fever


Structured Label Content

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

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose

Purpose

Pain reliever/fever reducer

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.

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.

Do Not Use (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 (Ask a Doctor)

your child has liver disease.

Active Ingredient

Acetaminophen 160mg

Other Information

www.sanarnaturals.com

Inactive Ingredients

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

Stop Use and Ask A Doctor (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)

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.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

your child is taking the blood thinning drug warfarin.

Sanar Naturals Children's Pain + Fever


Advanced Ingredient Data


Raw Label Data

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