Children's Acetaminophen Oral Suspension

Manufacturer
Cardinal Health 107, LLC
Effective date
2026-07-21
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-08-01 05:10:19

Label at a glance#

ProductChildrens Acetaminophen
Active ingredientACETAMINOPHEN
Label structure11 sections

Indications and uses

temporarily: • reduces fever • relieves minor aches and pain due to: o the common cold o flu o headache o sore throat o 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 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 (lbs) Age (yr) Dose (mL) or as directed by a docto...

Storage and handling

• each 5 mL contains: sodium 2 mg • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • protect from freezing • a red, berry flavored suspension supplied in the following oral dosage form: Overbagged with 5 x 5 mL unit dose cup in each bag, NDC 55154-5787-5 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the r...

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:

  • 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 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
• 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 of the inactive ingredients in this product.

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

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

When using this product, do not exceed the recommended dose (see overdose warning)

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 the reach of children.

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 for adults as well as children 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 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 (lbs)

Age (yr)

Dose (mL) *

Under 24

Under 2

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

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 2 mg
  • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
  • protect from freezing
  • a red, berry flavored suspension supplied in the following oral dosage form:

Overbagged with 5 x 5 mL unit dose cup in each bag, NDC 55154-5787-5

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

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

Call 1-800-845-8210.

SPL UNCLASSIFIED SECTION

MANUFACTURED BY

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

Distributed By:

Cardinal Health

Dublin, OH 43017

L55345730526

R09/20

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-5787-5

CHILDREN’S ACETAMINOPHEN

ORAL SUSPENSION

160 mg per 5 mL

5 UNIT-DOSE CUPS

160mg per 5mL bag label
160mg per 5mL bag label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130055154578752GTIN-13: 0055154578752
EAN-13: 0055154578752
GTIN-12: 055154578752
UPC-A: 055154578752
GTIN storage (14 digits): 00055154578752
520792e9-96f0-4445-9657-2df878274ef3-00.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1781-00ML - Milliliter0121-1781216b7a39-3839-44f8-ba3a-cf40c805602912017-06-15
0121-1781-05ML - Milliliter0121-17819246f12e-a346-4cc7-95b3-f112f0c7685112015-02-02

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
55154-578755154-5787-5
0121-1781

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92026-04-16full-release2026-06-01 01:54:54

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens AcetaminophenACETAMINOPHENCardinal Health 107, LLC7562f4e4-54fa-488c-a199-48ad2632e2a12026-07-21WarningsExact identifier
ndc (package): 55154-5787-5
ndc (product): 55154-5787
ndc11 (package): 55154578705
spl id: 921b627e-0a64-40f9-adab-b788a6e119f6
spl set id: 7562f4e4-54fa-488c-a199-48ad2632e2a1
Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma46d9d8cd-e3db-492c-9386-7e8255beff642024-10-08WarningsExact identifier
ndc (product): 0121-1781

Reported adverse events (FAERS/openFDA)#

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