DrKids Childrens Pain and Fever

Manufacturer
CalmCo LLC
Effective date
2024-12-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:43

Label at a glance#

ProductDrKids Childrens Pain and Fever
Active ingredientACETAMINOPHEN
Label structure8 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use do not give more than directed (see overdose warning) find right dose on the chart below. If possible, use weight to dose; otherwise, use age chocking hazard: instruct child to chew each piece thoroughly before swallowing repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Dosing Chart Weight (lbs) Age (...

Label contents#

Full prescribing information#

Active ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredient (in each piece)Purpose
Acetaminophen 80mg ..........................Pain reliever/ fever reducer

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains due to:

  • the common cold
  • flu
  • headache
  • sore throat
  • toothache
  • temporarily reduces fever

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.

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.

Ask a doctor before use 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.

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 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

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-12220 Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information

OTHER SAFETY INFORMATION

  • each piece contains: sodium 6 mg. low sodium
  • store in a cool dry place between 20-25°C (68-77°F).
  • Child Resistant Container; do not use if printed seal under cap is broken or missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

ammonium glycyrrhizate, flavors, geleol mono and diglycerides, glucode syrup, maltitol solution, maltodextrin, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-941-202-3270

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)
  • find right dose on the chart below. If possible, use weight to dose; otherwise, use age
  • chocking hazard: instruct child to chew each piece thoroughly before swallowing
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

Dosing Chart

Weight (lbs)

Age (Years)Dose (per piece)*
under 24under 2 yearsask a doctor
24-352-32
36-474-53
48-596-84
60-719-105
72-95116

*or as directed by a doctor

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label PDPlabel PDPlabel continuedlabel continued

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307696acetaminophen 80 MG Chewable TabletPSN2
307696acetaminophen 80 MG Chewable TabletSCD2
307696APAP 80 MG Chewable TabletSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73282-2480-1DrKids Childrens Pain and Fever24 in 1 BOTTLE, PLASTICBAR, CHEWABLE242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73282-2480DRKIDS CHILDRENS PAIN AND FEVER (ACETAMINOPHEN 80MG/PIECE) BAR, CHEWABLE [CALMCO LLC]2Current NDC, 1 package rows20241215_ff4b0528-39a0-80d5-e053-6394a90a8a83.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73282-248073282-2480-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
DrKids Childrens Pain and FeverACETAMINOPHEN 80MG/PIECECalmCo LLCff4b0528-39a0-80d5-e053-6394a90a8a832024-12-07WarningsExact identifier
ndc (package): 73282-2480-1
ndc (product): 73282-2480
ndc11 (package): 73282248001
spl id: 28b5f975-0ef9-dec2-e063-6394a90ac916
spl set id: ff4b0528-39a0-80d5-e053-6394a90a8a83

Reported adverse events (FAERS/openFDA)#

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