Childrens Pain and Fever

Manufacturer
AptaPharma Inc.
Effective date
2024-02-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:08:15

Label at a glance#

ProductChildrens Pain and Fever
Active ingredientACETAMINOPHEN
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
(in each 5 mL = 1 teaspoonful)
Acetaminophen 160 mg

OTC - PURPOSE SECTION

Purpose
Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings
Liver warning
This product contains acetaminophen. Severe liver
damage may occur nyour 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 ever, headache, rash.
nausea or vomiting, consult a doctor promptly.

OTC - DO NOT USE SECTION

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 other 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)

OTC - STOP USE SECTION

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 ■ 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.

OVERDOSAGE SECTION

Overdose warning:Taking more than the recommended dose (overdose)
may cause liver damage. 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.

DOSAGE & ADMINISTRATION SECTION

Directions (Children's Pain & Fever)
■ this product does not contain directions or complete warnings for adult use.
■ shake well before using
■ mL = milliliter; tsp = teaspoonful
■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age.
■ if needed, repeat dose every 4 hours while symptoms last
■ do not give more than 5 times in 24 hours
■ do not give for more than 5 days unless directed by a doctor.

 Weight (lb) Age (yr) Dose (mL or tsp)*
 under 24 under 2 years ask a doctor
 24-35 2 - 3 years 5 mL (1 tsp)
 36-47 4 - 5 years 7.5 mL (1 1/2 tsp0
 48-59 6 - 8 years 10 mL (2 tsp)
 60-71 9 - 10 years 12.5. mL (2 1/2 TSP)
 72-95 11 years 15 mL (3 tsp)

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically
designed for use with this product. Do not use any
other dosing device.

Directions (Infants' Pain Relief)
■ this product does not contain directions or complete warnings for adult use.
■ shake well before using
■ mL = milliliter; tsp = teaspoonful
■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age.
■ if needed, repeat dose every 4 hours while symptoms last
■ do not give more than 5 times in 24 hours
■ do not give for more than 5 days unless directed by a doctor.

 Weight (lb) Age (Yr) Dose (mL)*
 Under 24 Under 2 years Ask a doctor
 24-35 2-3 years 5 mL

*or as directed by a doctor

Attention: use only enclosed dosing syringe specifially
designed for use with this product. Do not use any
other dosing device.

OTHER SAFETY INFORMATION

Other information
■ each 5 mL (1 tsp) contains; sodium 3 mg
■ store between 20-25ºC (68-77ºF)
■ do not refrigerate
■ Keep carton for full directions for use.

INACTIVE INGREDIENT SECTION

Inactive ingredients anhydrous citric acid,
butylparaben. D&C Red #33. FD&C Blue #1. flavor,
glycerin, high fructose corn syrup, microcrystalline
cellulose and carboxymethylcellulose sodium.
propylene glycol, purified water, sodium benzoate,
sorbitol solution, sucralose, xanthan gum.

OTC - QUESTIONS SECTION

Questions? Call weekdays from 9:30 AM to 4:30

PM EST at 1-877-798-5944

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AP SAFE ®​                     NDC 76821-526-24

COMPARE TO THE

ACTIVE INGREDIENT IN

CHILDREN'S TYLENOL®

ORAL SUSPENSION*

Children's

Pain

& Fever

Acetaminophen

Oral Suspension

Pain reliever/Fever Reducer

• Alcohol-Free
• Ibuprofen Free
• Aspirin Free
• For Ages 2 to 11

4 FL OZ (118 mL)

160 mg per 5 mL

Grape Flavor

DO NOT USE IF PRINTED NECK BAND IS
BROKEN OR MISSING

**This product is not manufactured or distributed
by McNeil Consumer Healthcare, distributor of
Children's Tylenol®Oral Suspension.

Manufactured by:
AptaPharma Inc.
1533 Union Ave.
Pennsauken. NJ 08110

AP-BX-06

Carton

526-24 4OZ Box526-24 4OZ Box

Bottle

526-24 4OZ Btl526-24 4OZ Btl

Carton

526-23 03 2 Oz Box526-23 03 2 Oz Box

Bottle

526-23 03 2 Oz Botl526-23 03 2 Oz Botl

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN3
307668acetaminophen 32 MG/ML Oral SuspensionSCD3
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY3
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY3
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY3
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY3
307668APAP 32 MG/ML Oral SuspensionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76281-526-23Childrens Pain and Fever59 mL in 1 BOTTLESUSPENSION593
76281-526-23Childrens Pain and Fever1 in 1 CARTONSUSPENSION13
76281-526-24Childrens Pain and Fever1 in 1 CARTONSUSPENSION13
76281-526-24Childrens Pain and Fever118 mL in 1 BOTTLESUSPENSION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-526CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [APTAPHARMA INC.]3Current NDC, Legacy NDC, 4 package rows20240203_9064943f-836f-4853-b6f2-2c4879941eeb.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76281-52676281-526-24, 76281-526-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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 FeverACETAMINOPHENAptaPharma Inc.9064943f-836f-4853-b6f2-2c4879941eeb2024-02-02WarningsExact identifier
ndc (package): 76281-526-24
ndc (package): 76281-526-23
ndc (product): 76281-526
ndc11 (package): 76281052623
ndc11 (package): 76281052624
spl id: 5b15b381-438f-403f-8db3-ac8576244ea0
spl set id: 9064943f-836f-4853-b6f2-2c4879941eeb

Reported adverse events (FAERS/openFDA)#

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