Children's Pain Relief & Fever Reducer Oral Suspension Cherry

Children's Pain Relief & Fever Reducer Oral Suspension Cherry
SPL v3
SPL
SPL Set ID a2afaee7-19f3-4a42-a5b8-1d0ef3ecf009
Route
ORAL
Published
Effective Date 2024-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Butylparaben Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Cellulose, Microcrystalline Carboxymethylcellulose Sodium Propylene Glycol Water Sodium Benzoate Sorbitol Solution Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-28
Description

Drug Facts

Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses temporarily ■ reduces fever

■ relieves minor aches and pains due to:

■ the common cold ■ flu ■ headache ■ sore throat

■ toothache

Dosage and Administration

Directions

■ this product does not contain directions or

complete warnings for adult use.

■ shake well before using

■ mL = milliliter; tsp = teaspoonful

■ find the right dose on the chart below. If possible, use

weight to dose, otherwise, use age.

■ 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.

 Weight (lb)  Age (yr)  Dose (mL or tsp)*
 under 24  under 2 years  ask a doctor
 24-35  2 - 3 years  5 mL (1 tsp)
 36-47  4 - 5 years  7.5 mL (1 1/2 tsp)
 48-59  6 - 8 years  10 mL (2 tsp)
 60-71  9 - 10 years  12.5. mL (2 1/2 tsp)
 72-95  11 years  15 mL (3 tsp)

*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.

Description

Drug Facts

Section 34088-5

Overdose warning:Taking more than the recommended dose (overdose)

may cause liver damage. 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.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50567-7

When using this product do not exceed

recommended dose (see overdose warning)

Section 50568-5

Ask a doctor or pharmacist before use if your child

istaking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if your childhas liver disease.

Section 50570-1

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 other of

the inactive ingredients in this product.

Section 51727-6

Inactive ingredients   anhydrous citric acid,

butylparaben, FD&C red #40, flavor, glycerin, high

fructose corn syrup, microcrystalline cellulose and

carboxymethylcellulose sodium, propylene glycol,

purified water, sodium benzoate, sorbitol solution,

sucralose, xanthan gum.

Section 53413-1

Questions? Call 1-877-798-5944

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient

(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Section 60561-8

Other information

■ each 5 mL (1 tsp) contains; sodium 3 mg

■ store between 20-25ºC (68-77ºF)

■ do not refrigerate

■ Keep carton for full directions for use.

Package Labeling Puro Pharma Children's Pain & Fever Acetaminophen Oral Suspension Cherry Flavor

PURO

PHARMA              NDC 83474-001-04

COMPARE TO THE

ACTIVE INGREDIENT

IN CHILDREN'S TYLENOL

ORAL SUSPENSION*

PURO

PHARMA

Children's Pain & Fever

Acetaminophen

Oral Suspension

Pain reliever

Fever Reducer

• Ibuprofen Free

• Aspirin Free

• For Ages 2 to 11

4 FL OZ (118 mL)

160 mg per 5 mL

Cherry Flavor

This product is not manufactured or distributed by McNeil

Consumer Healthcare, distributor of Children's Tylenol ®

Oral Suspensin

Distributed by:

Puro Pharma Inc.

42 Catharine St. Poughkeepsie, NY 12601

[email protected]

BX-175

res

Structured Label Content

Indications and Usage (34067-9)

Uses temporarily ■ reduces fever

■ relieves minor aches and pains due to:

■ the common cold ■ flu ■ headache ■ sore throat

■ toothache

Dosage and Administration (34068-7)

Directions

■ this product does not contain directions or

complete warnings for adult use.

■ shake well before using

■ mL = milliliter; tsp = teaspoonful

■ find the right dose on the chart below. If possible, use

weight to dose, otherwise, use age.

■ 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.

 Weight (lb)  Age (yr)  Dose (mL or tsp)*
 under 24  under 2 years  ask a doctor
 24-35  2 - 3 years  5 mL (1 tsp)
 36-47  4 - 5 years  7.5 mL (1 1/2 tsp)
 48-59  6 - 8 years  10 mL (2 tsp)
 60-71  9 - 10 years  12.5. mL (2 1/2 tsp)
 72-95  11 years  15 mL (3 tsp)

*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.

Warnings and Precautions (34071-1)

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.

Section 34088-5 (34088-5)

Overdose warning:Taking more than the recommended dose (overdose)

may cause liver damage. 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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product do not exceed

recommended dose (see overdose warning)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if your child

istaking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if your childhas liver disease.

Section 50570-1 (50570-1)

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 other of

the inactive ingredients in this product.

Section 51727-6 (51727-6)

Inactive ingredients   anhydrous citric acid,

butylparaben, FD&C red #40, flavor, glycerin, high

fructose corn syrup, microcrystalline cellulose and

carboxymethylcellulose sodium, propylene glycol,

purified water, sodium benzoate, sorbitol solution,

sucralose, xanthan gum.

Section 53413-1 (53413-1)

Questions? Call 1-877-798-5944

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient

(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Section 60561-8 (60561-8)

Other information

■ each 5 mL (1 tsp) contains; sodium 3 mg

■ store between 20-25ºC (68-77ºF)

■ do not refrigerate

■ Keep carton for full directions for use.

Package Labeling Puro Pharma Children's Pain & Fever Acetaminophen Oral Suspension Cherry Flavor (Package Labeling PURO PHARMA Children's Pain & Fever Acetaminophen Oral Suspension Cherry Flavor)

PURO

PHARMA              NDC 83474-001-04

COMPARE TO THE

ACTIVE INGREDIENT

IN CHILDREN'S TYLENOL

ORAL SUSPENSION*

PURO

PHARMA

Children's Pain & Fever

Acetaminophen

Oral Suspension

Pain reliever

Fever Reducer

• Ibuprofen Free

• Aspirin Free

• For Ages 2 to 11

4 FL OZ (118 mL)

160 mg per 5 mL

Cherry Flavor

This product is not manufactured or distributed by McNeil

Consumer Healthcare, distributor of Children's Tylenol ®

Oral Suspensin

Distributed by:

Puro Pharma Inc.

42 Catharine St. Poughkeepsie, NY 12601

[email protected]

BX-175

res

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Source: dailymed · Ingested: 2026-02-15T12:07:55.683294 · Updated: 2026-03-14T23:11:56.566307