455 - Children Pain Relief Oral Suspension

Manufacturer
Allegiant Health
Effective date
2024-04-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:14:34

Label at a glance#

ProductChildrens Pain Relief
Active ingredientACETAMINOPHEN
Label structure9 sections

Dosage and administration

■ 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...

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg 

(in each 5 mL = 1 teaspoonful)

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Use(s)

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 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 ever, 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 other of the inactive ingredients in this product. 

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

your child has liver disease

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

your child is taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

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 ■ redness or swelling is present. These could be signs of a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN 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 (1-800-222-1222) right away. 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.■ 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(1 tsp)

36-47

4-5 years

7.5 mL(1 1/2 tsp)

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.

Other information

SPL UNCLASSIFIED SECTION

■ 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 ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, butylparaben, FD&C red
#40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and
carboxymethylcellulose sodium, propylene glycol, purified water, sodium
benzoate, sorbitol solution, sucralose, xanthan gum

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's Pain Relief
Children's Pain Relief

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
69168-455-53Childrens Pain Relief118 mL in 1 BOTTLELIQUID1183
69168-455-53Childrens Pain Relief1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-455CHILDRENS PAIN RELIEF LIQUID [ALLEGIANT HEALTH]3Current NDC, 2 package rows20240702_7381dd26-c507-4d02-b989-cfd96e02f495.zip

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
69168-45569168-455-53

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

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 ReliefCHILDRENS PAIN RELIEFAllegiant Health7381dd26-c507-4d02-b989-cfd96e02f4952024-04-11WarningsExact identifier
ndc (package): 69168-455-53
ndc (product): 69168-455
ndc11 (package): 69168045553
spl id: 29777790-246d-45ea-a6ef-1f1fb4241c84
spl set id: 7381dd26-c507-4d02-b989-cfd96e02f495

Reported adverse events (FAERS/openFDA)#

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