childrens fever reducer and pain reliever

Manufacturer
Rite Aid Corporation
Effective date
2024-05-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:12:14

Key Label Information#

Active Ingredients And Purpose

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

Uses

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

Warnings

Warnings

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.

Directions And Dosage

Directions

• this product does not contain directions or complete warnings for adult use • do not give 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. • remove the child protective cap and squeeze your child’s dose into the dosing cup • 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 Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Label Information

Other information

• each 5 mL contains : sodium 3 mg • store at 20-25 ° C (68-77 ° F) • do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredient of Children’s Tylenol ® Oral Suspension FREE FROM DYE FREE PARABEN FREE FOR AGES 2-11 YEARS CHILDREN’S FEVER REDUCER & PAIN RELIEVER ACETAMINOPHEN 160 mg/5 mL oral suspension aspirin free ibuprofen free CHERRY FLAVOR 4 FL OZ (118 mL)

Label Images#

image-01
image-01

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
11822-0959-1childrens fever reducer and pain reliever1 in 1 CARTONSUSPENSION13
11822-0959-1childrens fever reducer and pain reliever118 mL in 1 BOTTLESUSPENSION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0959CHILDRENS FEVER REDUCER AND PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [RITE AID CORPORATION]3Current NDC, Legacy NDC, 2 package rows20240509_7f445de3-30cf-4bd8-892d-05979cd399e7.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-095911822-0959-1

Ingredients#

Complete SPL Sections#

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 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.

Directions

DOSAGE & ADMINISTRATION SECTION

• this product does not contain directions or complete warnings for adult use • do not give 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. • remove the child protective cap and squeeze your child’s dose into the dosing cup • 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 Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

• each 5 mL contains : sodium 3 mg • store at 20-25 ° C (68-77 ° F) • do not use if printed neckband is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient of Children’s Tylenol ® Oral Suspension FREE FROM DYE FREE PARABEN FREE FOR AGES 2-11 YEARS CHILDREN’S FEVER REDUCER & PAIN RELIEVER ACETAMINOPHEN 160 mg/5 mL oral suspension aspirin free ibuprofen free CHERRY FLAVOR 4 FL OZ (118 mL)

Source Document#

Source XML