FDA.reportPublic FDA data

Childen's Acetaminophen Oral Suspension

Manufacturer
Pharmaceutical Associates, Inc.
Effective date
2022-08-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:55:41

Label at a glance#

ProductChildrens Acetaminophen
Active ingredientACETAMINOPHEN
Label structure12 sections

Indications and uses

temporarily: reduces fever relieves minor aches and pains 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. • 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 ...

Storage and handling

 each 5 mL contains: sodium: 2 mg  Store at 20° to 25°C (68° to 77°F)  berry flavored suspension supplied in the following oral dosage forms:  NDC 0121-0939-05: 5 mL unit dose cup, in a tray of ten cups.  NDC 0121-1878-10: 10 mL unit dose cup, in a tray of ten cups.

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION

temporarily:

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

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

SPL UNCLASSIFIED SECTION

Drug Facts

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if

  • • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen

Allergy alert

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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 you have ever had an allergic reaction to this product or any of its ingredients

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the user has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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.

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.

    • 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 2 yearsask a doctor
24-352-3 years5 mL
36-474-5 years7.5 mL
48-596-8 years10 mL
60-719-10 years12.5 mL
72-9511 years15 mL
Over 96adults and children 12 years and over20 mL

Other information

STORAGE AND HANDLING SECTION

  •  each 5 mL contains: sodium: 2 mg
  •  Store at 20° to 25°C (68° to 77°F)
  •  berry flavored suspension supplied in the following oral dosage forms:
     NDC 0121-0939-05: 5 mL unit dose cup, in a tray of ten cups.
     NDC 0121-1878-10: 10 mL unit dose cup, in a tray of ten cups.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

OTC - QUESTIONS SECTION

Call 1-800-845-8210.

SPL UNCLASSIFIED SECTION

Manfactured By

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 0121-0939-05

CHILDREN'S ACTAMINOPHEN ORAL SUSPENSION

160 mg per 5 mL

DYE FREE

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

SEE INSERT

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 0121-1878-10

CHILDREN'S ACTAMINOPHEN ORAL SUSPENSION 

320 mg per 10 mL

DYE FREE

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

SEE INSERT

PRINCIPAL DISPLAY PANEL - 10 mL Cup Label
PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0939-00ML - Milliliter0121-09395799ee65-baa4-47d9-be21-2c517734457312021-04-08
0121-0939-05ML - Milliliter0121-0939e3e18c0c-356a-437e-8b5e-dc393763e47412021-04-08

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0121-09390121-0939-05, 0121-0939-00
0121-18780121-1878-10, 0121-1878-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
BUTYLPARABEN3QPI1U3FV8IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL SOLUTION8KW3E207O2IACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
BUTYLPARABEN3QPI1U3FV8IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL SOLUTION8KW3E207O2IACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB

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
6106e932-093d-406c-ac3c-27a070ab36bdb9bccbf8-f9c4-abe7-e053-2995a90a943e2024-05-07WarningsExact identifier
spl set id: b9bccbf8-f9c4-abe7-e053-2995a90a943e

Reported adverse events (FAERS/openFDA)#

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