Children's Pain Relief & Fever Reducer Oral Suspension Cherry

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient(in each 5 mL = 1 teaspoonful)Acetaminophen 160 mg

OTC - PURPOSE SECTION

PurposePain reliever/fever reducer

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

WarningsLiver warningThis product contains acetaminophen. Severe liverdamage may occur if your child takes: ■ more than 5doses in 24 hours, which is the maximum daily amount■ with other drugs containing acetaminophen

Allergy alert: acetaminophen may cause severe skinreactions. Symptoms may include: ■ skin reddening■ blisters ■ rashIf a skin reaction occurs, stop use and seek medical helpright away.

Sore throat warningIf 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.

OTC - DO NOT USE SECTION

Do not use■ with any other drug containing acetaminophen(prescription or nonprescription). If you are not surewhether a drug contains acetaminophen, ask a doctoror pharmacist.■ If your child is allergic to acetaminophen or any other ofthe inactive ingredients in this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child

is taking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

When using this product do not exceed

recommended dose (see overdose warning)

OTC - STOP USE SECTION

Stop use and ask a doctor if■ pain gets worse or lasts more than 5 days ■ fevergets worse or lasts more than 3 days ■ newsymptoms occur ■ redness or swelling is present.These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

Overdose warning:Taking more than the recommended dose (overdose)may cause liver damage. In case of overdose, getmedical help or contact a Poison Control Center rightaway. (1-800-222-1222) Quick medical attention is criticalfor adults as well as for children even if youdo not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions■ this product does not contain directions orcomplete warnings for adult use.■ shake well before using■ mL = milliliter; tsp = teaspoonful■ find the right dose on the chart below. If possible, useweight to dose, otherwise, use age.■ if needed, repeat dose every 4 hours whilesymptoms last■ do not give more than 5 times in 24 hours■ do not give for more than 5 days unless directedby a doctor.

*or as directed by a doctor

Attention: use only enclosed dosing cup specificallydesigned for use with this product. Do not use anyother dosing device.

OTHER SAFETY INFORMATION

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.

INACTIVE INGREDIENT SECTION

Inactive ingredients  anhydrous citric acid,butylparaben, FD&C red #40, flavor, glycerin, highfructose corn syrup, microcrystalline cellulose andcarboxymethylcellulose sodium, propylene glycol,purified water, sodium benzoate, sorbitol solution,sucralose, xanthan gum.

OTC - QUESTIONS SECTION

Questions? Call 1-877-798-5944

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

Info@puro-pharma.com

BX-175

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