Children's

Children's
SPL v1
SPL
SPL Set ID 7eb3f185-6b4a-4674-8658-79132b1f6aec
Route
ORAL
Published
Effective Date 2010-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Cherry Citric Acid Monohydrate Corn Syrup Fd&c Red No. 40 Glycerin Cellulose, Microcrystalline Carboxymethylcellulose Sodium Propylene Glycol Water Sodium Benzoate Sucralose Sorbitol Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-01-04
Description

Drug Facts

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

temporarily relieves minor aches and pains due to:

  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if the child has liver disease.

Section 50570-1

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.

Directions
  • shake well before using
  • if needed, repeat dose every 4 hours
  • do not use more than 5 times in 24 hours
  • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
  • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
Age (yr) Dose (mL or tsp)
under 2 years ask a doctor
2-3 years 5 mL or 1 tsp.
4-5 years 7.5 mL or 1½ tsp.
6-8 years 10 mL or 2 tsp.
9-10 years 12.5 mL or 2½ tsp.
11 years 15 mL or 3 tsp.
Questions?

877-434-2036

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.
Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical, even if you do not notice any signs or symptoms.

Other Information
  • each teaspoon contains: sodium 2 mg
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.

Inactive Ingredients

artificial flavor, citric acid, corn syrup, FD&C red #40, glycerin, microcrystalline cellulose and carboxymethyl cellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

When Using This Product

Do not exceed recommended dose.

Storage & Package Safety
  • do not use if inner foil seal is broken or missing
  • store between 20°-25°C (68°-77°F)
  • see bottom panel for lot number and expiration date
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.

Principal Display Panel 120 Ml Carton

CHILDREN'S

ACCUDIAL

ROTATING DOSING LABEL

ACCURATE DOSING BY WEIGHT

CONTAINS

Acetaminophen

Oral Suspension

Pain Reliever,

Fever Reducer

For Ages 2 to under 12

Alcohol Free • Aspirin Free • Ibuprofen Free

80 mg per 1/2 teaspoon

(160 mg per 5 mL)

CHERRY

FLAVOR

Compares to

Children's

Tylenol ®.

4 FL.OZ.

(120 mL)

NDC 45014-131-04

Active Ingredient (in Each 5 Ml = 1 Teaspoon)

Acetaminophen 160 mg

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:

  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if the child has liver disease.

Section 50570-1 (50570-1)

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.

Purpose

Pain reliever/fever reducer

Directions
  • shake well before using
  • if needed, repeat dose every 4 hours
  • do not use more than 5 times in 24 hours
  • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
  • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
Age (yr) Dose (mL or tsp)
under 2 years ask a doctor
2-3 years 5 mL or 1 tsp.
4-5 years 7.5 mL or 1½ tsp.
6-8 years 10 mL or 2 tsp.
9-10 years 12.5 mL or 2½ tsp.
11 years 15 mL or 3 tsp.
Questions?

877-434-2036

Liver Warning (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.
Overdose Warning (Overdose warning)

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical, even if you do not notice any signs or symptoms.

Other Information (Other information)
  • each teaspoon contains: sodium 2 mg
Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

artificial flavor, citric acid, corn syrup, FD&C red #40, glycerin, microcrystalline cellulose and carboxymethyl cellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

When Using This Product (When using this product)

Do not exceed recommended dose.

Storage & Package Safety
  • do not use if inner foil seal is broken or missing
  • store between 20°-25°C (68°-77°F)
  • see bottom panel for lot number and expiration date
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.

Principal Display Panel 120 Ml Carton (PRINCIPAL DISPLAY PANEL - 120 mL Carton)

CHILDREN'S

ACCUDIAL

ROTATING DOSING LABEL

ACCURATE DOSING BY WEIGHT

CONTAINS

Acetaminophen

Oral Suspension

Pain Reliever,

Fever Reducer

For Ages 2 to under 12

Alcohol Free • Aspirin Free • Ibuprofen Free

80 mg per 1/2 teaspoon

(160 mg per 5 mL)

CHERRY

FLAVOR

Compares to

Children's

Tylenol ®.

4 FL.OZ.

(120 mL)

NDC 45014-131-04

Active Ingredient (in Each 5 Ml = 1 Teaspoon) (Active ingredient (in each 5 mL = 1 teaspoon))

Acetaminophen 160 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:00.112982 · Updated: 2026-03-14T22:52:17.029964