Label at a glance#

ProductChildrens Acetaminophen

Active ingredientACETAMINOPHEN

Label structure11 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 a doctor 24-35 ...

Storage and handling

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 forms: NDC 0121-0946-05: 5 mL unit dose cup, in a tray of ten cups.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-845-8210

Websitewww.paipharma.com

www.paipharma.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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 pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache

WARNINGS

WARNINGS SECTION

Liver warnings

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:

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: 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 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

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.

OVERDOSAGE 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 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

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

STORAGE AND HANDLING 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 forms:

NDC 0121-0946-05: 5 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.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-845-8210.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

MANUFACTURED BY

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R06/21

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Delivers 5 mL
NDC 0121-0946-05

Children's Acetaminophen Oral Suspension

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Package Not Child-Resistant

Rx ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

A0946050621

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

Products#

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

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

Childrens Acetaminophen
ACESULFAME POTASSIUM
BUTYLPARABEN
ANHYDROUS CITRIC ACID
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SORBITOL SOLUTION
XANTHAN GUM
ACETAMINOPHEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0121-0946	0121-0946-05, 0121-0946-30, 0121-0946-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GLYCERIN	PDC6A3C0OX	IACT
HIGH FRUCTOSE CORN SYRUP	XY6UN3QB6S	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SORBITOL SOLUTION	8KW3E207O2	IACT
XANTHAN GUM	TTV12P4NEE	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
23aa7382-5871-0f85-e063-6394a90a1c3b			287d1a63-0197-423a-83a1-b40c474f7ac5	2024-10-04	Warnings	Exact identifier spl set id: 287d1a63-0197-423a-83a1-b40c474f7ac5

Reported adverse events (FAERS/openFDA)#

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