Childrens Pain and Fever

Manufacturer
Discount Drug Mart | AptaPharma Inc.
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:28:37

Label at a glance#

ProductChildrens Pain and Fever
Active ingredientACETAMINOPHEN
Label structure16 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. shake well before using mL = millititer; tsp = teaspoonful find right dose on chart below. If possible, use weight to dose, otherwise, use age. if needed, repeat dose every 4 hours while symptoms last do not give for more than 5 days unless directed by a doctor Weight (lb)        Age (yr)            Dose (mL or Tsp)* under 24           un...

Label contents#

Full prescribing information#

Drug FactsActive ingredient(in each 5 mL = 1 teaspoonful)

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 maxium daily amount
  • with other drugs containing acteaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stopuse and seek medical help right away.

Sore throat warning: If a sore throat is severe, persiss 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 to any of the inactive ingredients in this product

Ask a doctor if your child has

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

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.

Keep out of reach of children.

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 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 = millititer; tsp = teaspoonful
  • find right dose on chart below. If possible, use weight to dose, otherwise, use age.
  • if needed, repeat dose every 4 hours while symptoms last
  • 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 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

* or as directed by a doctor

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

Other information

OTHER SAFETY INFORMATION

  • eash 5mL (1 tsp) contains sodium 3mg
  • store between 20-25

Inactive ingrediants

INACTIVE INGREDIENT SECTION

anhydrous citric acid, butylparaben, D&C Red # 33, FD&C (red), flavor, glycerin, flavor, high frucotose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum   

Questions

OTC - QUESTIONS SECTION

Call weekays from 9:30 AM to 4:30 PM

Children's Pain & Fever product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISCOUNT
drug mart
FOOD FAIR

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S TYLENOL® ORAL SUSPENSION

Fever Reducer / Pain Reliever

Children's Pain & Fever

Acetaminophen Oral Suspension

  • Alcohol-Free
  • Ibuprofen Free
  • Aspirin Free

For Ages 2 to 11

GRAPE FLAVOR

4 FL OZ (118 mL)
160 mg per 5 mmL

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

BX-053

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STOORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

AptaPharmDD ChildPainFever 526AptaPharmDD ChildPainFever 526

AptaPharmDD ChildPainFever 526 1AptaPharmDD ChildPainFever 526 1

res

AptaPharmDD ChildPainFever 526AptaPharmDD ChildPainFever 526

AptaPharmDD ChildPainFever 526 1AptaPharmDD ChildPainFever 526 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN5
307668acetaminophen 32 MG/ML Oral SuspensionSCD5
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY5
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY5
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY5
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY5
307668APAP 32 MG/ML Oral SuspensionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-526-24Childrens Pain and Fever118 mL in 1 BOTTLELIQUID1185

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
53943-52653943-526-24

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 · Source PDF

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 FeverACETAMINOPHENDiscount Drug Mart2aa0f9f3-924c-4a4a-bb5f-2a326acc24082025-12-26WarningsExact identifier
ndc (package): 53943-526-24
ndc (product): 53943-526
ndc11 (package): 53943052624
spl id: 6747b911-0241-46c0-85ef-beb3cc21b682
spl set id: 2aa0f9f3-924c-4a4a-bb5f-2a326acc2408

Reported adverse events (FAERS/openFDA)#

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