children's acetaminophen oral suspension

children's acetaminophen oral suspension
SPL v1
SPL
SPL Set ID de53e048-a13d-4f9b-8e5c-b5449ff47078
Route
oral
Published
Effective Date 2013-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (160 mg)
Inactive Ingredients
anhydrous citric acid butylparaben carboxymethylcellulose sodium carrageenan d&c red no. 33 fd&c blue no. 1 glycerin high fructose corn syrup hydroxyethyl cellulose (100 mpa.s at 2%) cellulose, microcrystalline propylene glycol water sodium benzoate sorbitol

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
otc monograph not final active Since 2013-09-23
Purpose

Pain reliever/fever reducer

Description

Drug Facts

Medication Information

Uses

temporarily:

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

Pain reliever/fever reducer

Directions
  • do not give more than directed (see Liver and overdose warning)
  • shake well before use
  • this product does not contain directions or complete warnings for adult use
  • use only with enclosed dosing cup
  • repeat dose every 4 hours if needed
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
  • find right dose on chart below. If possible, use weight to dose, otherwise; use age.
Weight (lb) Age (yr) Dose (tsp or mL)
under 24 under 2 years ask a doctor
24-35 2-3 years 1 tsp or 5 mL
36-47 4-5 years 1 1/2 tsp or 7.5 mL
48-59 6-8 years 2 tsp or 10 mL
60-71 9-10 years 2 1/2 tsp or 12.5 mL
72-95 11 years 3 tsp or 15 mL
Other Information
  • each teaspoon contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Description

Drug Facts

Questions?

Call 601-859-0038

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not exceed recommended dose (see overdose warning)

Section 50568-5

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

Section 50569-3

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

Do Not Use
  • with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
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 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.

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.

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.

Active Ingredient (in Each 5 Ml = 1 Teaspoon)

Acetaminophen 160 mg

Principal Display Panel 118 Ml Bottle Carton

NDC 59999-001-04

SEE NEW WARNINGS INFORMATION

*Compare to the active ingredient in

Children's Tylenol® Oral Suspension*

Children's

Acetaminophen

oral suspension

80 mg per 1/2 teaspoon

(160 mg per 5 mL)

fever reducer/

pain reliever

AGE

2-11

YEARS

Grape Flavor

R3 Pharmaceuticals

4 FL OZ (118 mL)

Structured Label Content

Uses

temporarily:

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

Pain reliever/fever reducer

Directions
  • do not give more than directed (see Liver and overdose warning)
  • shake well before use
  • this product does not contain directions or complete warnings for adult use
  • use only with enclosed dosing cup
  • repeat dose every 4 hours if needed
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
  • find right dose on chart below. If possible, use weight to dose, otherwise; use age.
Weight (lb) Age (yr) Dose (tsp or mL)
under 24 under 2 years ask a doctor
24-35 2-3 years 1 tsp or 5 mL
36-47 4-5 years 1 1/2 tsp or 7.5 mL
48-59 6-8 years 2 tsp or 10 mL
60-71 9-10 years 2 1/2 tsp or 12.5 mL
72-95 11 years 3 tsp or 15 mL
Other Information (Other information)
  • each teaspoon contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Questions?

Call 601-859-0038

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose (see overdose warning)

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

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

Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
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 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.

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.

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.

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

Acetaminophen 160 mg

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

NDC 59999-001-04

SEE NEW WARNINGS INFORMATION

*Compare to the active ingredient in

Children's Tylenol® Oral Suspension*

Children's

Acetaminophen

oral suspension

80 mg per 1/2 teaspoon

(160 mg per 5 mL)

fever reducer/

pain reliever

AGE

2-11

YEARS

Grape Flavor

R3 Pharmaceuticals

4 FL OZ (118 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:42.079663 · Updated: 2026-03-14T22:53:35.925326