Childrens Pain Relief and Fever Reducer Oral Suspension Cherry

Manufacturer
Puro Pharma Inc.
Effective date
2025-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:28:54

Label at a glance#

ProductChildrens Pain Relief and Fever Reducer Oral Suspension Cherry
Active ingredientACETAMINOPHEN
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose
Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your childhas liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child

istaking 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 ■ 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.

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, 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.

DOSAGE & ADMINISTRATION SECTION

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.

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, high
fructose corn syrup, microcrystalline cellulose and
carboxymethylcellulose 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

001-04 Cherry Box001-04 Cherry Box

001-04 Bottl Cherry001-04 Bottl Cherry

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN3
307668acetaminophen 32 MG/ML Oral SuspensionSCD3
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY3
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY3
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY3
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY3
307668APAP 32 MG/ML Oral SuspensionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83474-001-04Childrens Pain Relief and Fever Reducer Oral Suspension Cherry1 in 1 CARTONSUSPENSION13
83474-001-04Childrens Pain Relief and Fever Reducer Oral Suspension Cherry118 mL in 1 BOTTLESUSPENSION1183

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83474-001-04ML - Milliliter83474-001a0e92883-23a7-4f7e-9bfb-3170eba185a312024-07-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83474-00183474-001-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Pain Relief and Fever Reducer Oral Suspension CherryACETAMINOPHENPuro Pharma Inc.a2afaee7-19f3-4a42-a5b8-1d0ef3ecf0092025-12-27WarningsExact identifier
ndc (package): 83474-001-04
ndc (product): 83474-001
ndc11 (package): 83474000104
spl id: 46f2d5ac-91bc-922f-e063-6394a90af4ed
spl set id: a2afaee7-19f3-4a42-a5b8-1d0ef3ecf009

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.