Dye Free Childrens Acetaminophen

Manufacturer
PAI Holdings, LLC dba PAI Pharma | PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Effective date
2025-02-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:54:30

Label at a glance#

ProductDye Free Childrens Acetaminophen
Active ingredientACETAMINOPHEN
Label structure15 sections

Indications and uses

reduces fever 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 Attention: For Single-Dose Cups, the entire dose should be taken. Weight (...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL)
Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Acetaminophen
160 mg.............................Pain reliever/fever reducer

Uses temporarily:

INDICATIONS & USAGE SECTION

  • reduces fever
  • minor aches and pains 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 non-prescription). 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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child 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:

OVERDOSAGE 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 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 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

Attention: For Single-Dose Cups, the entire dose should be taken.

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

Other information

SPL UNCLASSIFIED SECTION

  • each 5 mL contains: sodium: 2 mg
  • Store at 20° to 25°C (68° to 77°F)
  • grape flavored suspension supplied in the following oral dosage form:

   NDC 0121-0966-05: 5 mL unit dose cup, in a tray of ten cups.

   NDC 0121-0966-94: Case contains 30 unit dose cups of 5 mL (0121-0966-05) packaged in 3 trays of 10 unit dose cups each.
   NDC 0121-0966-00: Case contains 100 unit dose cups of 5 mL (0121-0966-05) packaged in 10 trays of 10 unit dose cups each.

INACTIVE INGREDIENT SECTION

Inactive ingredients: 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.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210.

MANUFACTURED BY:

SPL UNCLASSIFIED SECTION

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R01/22

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 0121-0966-05

DYE FREE/GRAPE FLAVOR

Children's Acetaminophen Oral Suspension

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

SEE INSERT

Children's Acetaminophen Oral Suspension
Children's Acetaminophen Oral Suspension

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN8
307668acetaminophen 32 MG/ML Oral SuspensionSCD8
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY8
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY8
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY8
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY8
307668APAP 32 MG/ML Oral SuspensionSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0966-00Dye Free Childrens Acetaminophen10 in 1 CASESUSPENSION108
0121-0966-00Dye Free Childrens Acetaminophen10 in 1 TRAYSUSPENSION108
0121-0966-05Dye Free Childrens Acetaminophen5 mL in 1 CUP, UNIT-DOSESUSPENSION58
0121-0966-94Dye Free Childrens Acetaminophen10 in 1 TRAYSUSPENSION108
0121-0966-94Dye Free Childrens Acetaminophen3 in 1 CASESUSPENSION38

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0966DYE FREE CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]8Current NDC, Legacy NDC, 5 package rows20250207_a69fca9d-c0a0-4321-bf03-5c8e99cc07cc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0966-00ML - Milliliter0121-096624875b41-aea9-4700-8655-d4c10512f1fd12022-04-06
0121-0966-05ML - Milliliter0121-09660653823a-bbba-4745-a69c-73b118f2c98512022-04-06
0121-0966-94ML - Milliliter0121-0966c360af38-f12d-4bd7-84c2-0fc30ab9d79112022-04-06

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0121-09660121-0966-05, 0121-0966-94, 0121-0966-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
Dye Free Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmaa69fca9d-c0a0-4321-bf03-5c8e99cc07cc2025-02-04WarningsExact identifier
ndc (package): 0121-0966-05
ndc (package): 0121-0966-94
ndc (package): 0121-0966-00
ndc (product): 0121-0966
ndc11 (package): 00121096694
ndc11 (package): 00121096605
ndc11 (package): 00121096600
spl id: 89d3db5b-5a3b-41d3-b2d1-223932ba25d1
spl set id: a69fca9d-c0a0-4321-bf03-5c8e99cc07cc

Reported adverse events (FAERS/openFDA)#

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