Childrens Pain and Fever

Manufacturer
PAI Holdings, LLC dba PAI Pharma
Effective date
2024-01-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:02:36

Label at a glance#

ProductChildrens Pain and Fever
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

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

Dosage and administration

• this product does not contain directions or complete   warnings for adult use • do not take 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 g...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL)
Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/ fever reducer

Uses temporarily:

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

Do not use

OTC - DO NOT USE SECTION

• 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 has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if your child has

OTC - ASK DOCTOR SECTION

 liver disease

Ask a doctor or pharmacist before use if your child is taking
the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any sign or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

• this product does not contain directions or complete
  warnings for adult use
• do not take 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.

Other information

SPL UNCLASSIFIED SECTION

• each 5 mL contains: sodium: 2 mg
• store at 20° to 25°C (68° to 77°F)
• do not use if printed neckband is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame K, butylparaben, citric acid, FD&C Red No. 40, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium
benzoate, sorbitol solution, veegum and xanthan gum.

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-845-8210

**This product is not manufactured or distributed by
Johnson & Johnson Consumer Inc., distributor of
Children’s Tylenol® Oral Suspension.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2022 CVS/pharmacy
CVS.com® 1-800-SHOP CVS

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Children’s Tylenol® Oral Suspension**

Suspension Liquid

NDC 0121-0975-08

Children’s Pain & Fever

ACETAMINOPHEN

160 mg / 5 mL

Pain reliever; Fever reducer

Ages 2 to 11 years

Free of:

 • Added Alcohol

 • Aspirin

• Ibuprofen 

Cherry Flavor

Use ONLY Enclosed Dosing Cup

Actual Bottle Size on Side Panel

8 FL OZ (237 mL)

Childrens Pain and FeverChildrens Pain and Fever

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
0121-09750121-0975-08

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
0142deb8-6996-4316-9ffc-3bf7b41b3da38433ca51-ff47-40ea-bc40-976e5b3182fc2024-01-17WarningsExact identifier
spl id: 0142deb8-6996-4316-9ffc-3bf7b41b3da3
spl set id: 8433ca51-ff47-40ea-bc40-976e5b3182fc

Reported adverse events (FAERS/openFDA)#

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