Childrens Pain and Fever

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | LNK International, Inc.
Effective date
2026-02-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:47:19

Label at a glance#

ProductChildrens Pain and Fever
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL = milliliter only use the dose cup provided find the right dose on chart below. If possible, use weight to dose; otherwise, use age. 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 Ask a doctor ...

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

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.

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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
  • redness or swelling is present
  • any new symptoms appear

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using
  • mL = milliliter
  • only use the dose cup provided
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • 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 24Under 2Ask a doctor
24-352-35 mL
36-474-57.5 mL
48-596-810 mL
60-719-1012.5 mL
72-951115 mL

*or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51316-098-19

♥︎CVS™

Ages
2–11
years 

Grape Flavor

Children’s
PAIN & FEVER

Acetaminophen
160 mg / 5 mL
Oral Suspension
Pain Reliever, Fever Reducer

Compare to Children’s Tylenol® 
Oral Suspension active ingredient†

Free of:
Aspirin, Ibuprofen
No Added Alcohol

DYE
FREE

8 FL OZ (237 mL)

dosing cup
included

DIRECTIONS:

Step 1.
Shake well 
before using

Step 2.
Remove child
protective cap

Step 3.
Pour your 
child’s dose 
into the 
dosing cup

IMPORTANT:
Please see dosing chart or ask a doctor for
your child’s correct dose

TAMPER EVIDENT: DO NOT USE IF PRINTED
NECK WRAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Kenvue
Inc., owner of the registered trademark Children’s Tylenol®
Oral Suspension.

50844     ORG022409819

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2026 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-39965

♥︎ 100% money back
guaranteed.

CVS.com/returnpolicy

CVS 44-098
CVS 44-098

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN6
307668acetaminophen 32 MG/ML Oral SuspensionSCD6
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY6
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY6
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY6
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY6
307668APAP 32 MG/ML Oral SuspensionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-098-19Childrens Pain and Fever1 in 1 CARTONSUSPENSION16
51316-098-19Childrens Pain and Fever237 mL in 1 BOTTLE, PLASTICSUSPENSION2376
51316-098-36Childrens Pain and Fever1 in 1 CARTONSUSPENSION16
51316-098-36Childrens Pain and Fever118 mL in 1 BOTTLE, PLASTICSUSPENSION1186

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-09851316-098-19, 51316-098-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd96a1531-772b-4a5c-89e4-66fff1fa3d782026-02-25WarningsExact identifier
ndc (package): 51316-098-36
ndc (package): 51316-098-19
ndc (product): 51316-098
ndc11 (package): 51316009836
ndc11 (package): 51316009819
spl id: dc7442bd-8264-4b7a-a069-5c2d28e68e90
spl set id: d96a1531-772b-4a5c-89e4-66fff1fa3d78

Reported adverse events (FAERS/openFDA)#

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