Drkids Children's Pain And Fever (usp)

Drkids Children's Pain And Fever (usp)
SPL v2
SPL
SPL Set ID ff4b0528-39a0-80d5-e053-6394a90a8a83
Route
ORAL
Published
Effective Date 2023-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (80 mg)
Inactive Ingredients
Ammonium Glycyrrhizate Glyceryl Mono And Dipalmitostearate Maltitol Polyethylene Glycol 400 Neotame Starch, Corn Propylene Glycol Water Carrageenan Sucrose Sucralose Corn Syrup Sodium Chloride Trisodium Citrate Dihydrate Povidone K30 Maltodextrin

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: white Size: 15 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-01
Description

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

Medication Information

Description

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

Uses

Temporarily relieves minor aches and pains due to:

  • the common cold
  • flu
  • headache
  • sore throat
  • toothache
  • temporarily reduces fever
Section 55105-1
Active Ingredient (in each piece) Purpose
Acetaminophen 80mg .......................... Pain reliever/ fever reducer

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
  • 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 24 under 2 years ask a doctor
24-35 2-3 2
36-47 4-5 3
48-59 6-8 4
60-71 9-10 5
72-95 11 6

*or as directed by a doctor

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 of the inactive ingredients in this product.
Other 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

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?

Call 1-941-202-3270

Principal Display Panel

When Using This Product

do not exceed recommended dose (see overdose warning)

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 occur
  • redness or swelling is present. These could be signs of a serious condition.
Keep Out of Reach of Children.

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.

Ask A Doctor Before Use If Your Child Has

liver disease

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin.

Structured Label Content

Uses

Temporarily relieves minor aches and pains due to:

  • the common cold
  • flu
  • headache
  • sore throat
  • toothache
  • temporarily reduces fever
Section 55105-1 (55105-1)
Active Ingredient (in each piece) Purpose
Acetaminophen 80mg .......................... Pain reliever/ fever reducer

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
  • 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 24 under 2 years ask a doctor
24-35 2-3 2
36-47 4-5 3
48-59 6-8 4
60-71 9-10 5
72-95 11 6

*or as directed by a doctor

Do Not Use (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 of the inactive ingredients in this product.
Other 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

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? (Questions or comments?)

Call 1-941-202-3270

Principal Display Panel

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)

Stop Use and Ask A Doctor If (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 occur
  • redness or swelling is present. These could be signs of a serious condition.
Keep Out of Reach of Children. (Keep out of reach of children.)

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.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:50.531005 · Updated: 2026-03-14T23:05:53.122655