Acetaminophen

Acetaminophen
SPL v3
SPL
SPL Set ID 4c396d0e-aa93-4f9e-b065-2e606f7f05cd
Route
ORAL
Published
Effective Date 2025-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Red No. 40 Polyethylene Glycol, Unspecified Water Sorbitol Sodium Benzoate Sodium Citrate, Unspecified Form Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-10
Description

Drug Facts

Purpose

Pain reliever/Fever reducer

Medication Information

Purpose

Pain reliever/Fever reducer

Description

Drug Facts

Uses

For the temporary relief of minor aches and pains associated with:

• the common cold

• flu 

• sore throat 

• headache

• toothache 

• and to reduce fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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.

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.

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.

Stop use and ask a doctor if• pain gets worse or lasts more than 5 days 

  • pain gets worse or lasts more than 5 day.
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present.
  • any new symotom appear.

These could be signs of a serious condition.

Directions
  • this product does not contain directions or complete warnings for adult use
  • Use only the enclosed dosing cup designed for use with this product.
  • if possible, use weight to dose, otherwise use age.
  • dose may be repeated every 4 hours, while symptoms persist, up to five times a day or as directed by a doctor.

 Weight (lbs.)

Age (years) Dosage Teaspoonful (tsp)*
Under 24  Under 2  Consult a doctor
24 to 35      2 to under 4    5 mL (1 tsp)  
36 to 47      4 to under 6    7.5 mL (1 1/2 tsp)
48 to 59      6 to under 9   10 mL (2 tsp)
60 to 71  9 to under 11   12.5 mL (2 1/2 tsp) 
72 to 95  11 to under 12   15 mL (3 tsp)

* or as directed by a doctor

Questions?

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Other Information
  • Each 5 mL contains: Sodium 3 mg
  • If dispensed, dispense in a tight, light resistant container with a child-resistant cap.
  • Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)
Inactive Ingredients

Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution, Sucralose.

Principal Display Panel

ONCOR PHARMACEUTICALS

NDC 83720- 500-16

Pain and

Fever Relief

kids

Acetaminophen

Liquid 160 mg / 5 mL

Alcohol Free

Sugar Free

Aspirin Free

Ibuprofen Free

Cherry Flavor

16 fl. oz. - 473 mL

ONCOR PHARMACEUTICALS

NDC 83720- 500-16

Pain and

Fever Relief

kids

Acetaminophen

Liquid 160 mg / 5 mL

Alcohol Free

Sugar Free

Aspirin Free

Ibuprofen Free

Cherry Flavor

4 fl. oz. - 118 mL

Active Ingredient (in Each 5 Ml Teaspoonful)

Acetaminophen, USP 160 mg

Structured Label Content

Uses

For the temporary relief of minor aches and pains associated with:

• the common cold

• flu 

• sore throat 

• headache

• toothache 

• and to reduce fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Purpose

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.

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.

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.

Stop use and ask a doctor if• pain gets worse or lasts more than 5 days 

  • pain gets worse or lasts more than 5 day.
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present.
  • any new symotom appear.

These could be signs of a serious condition.

Directions
  • this product does not contain directions or complete warnings for adult use
  • Use only the enclosed dosing cup designed for use with this product.
  • if possible, use weight to dose, otherwise use age.
  • dose may be repeated every 4 hours, while symptoms persist, up to five times a day or as directed by a doctor.

 Weight (lbs.)

Age (years) Dosage Teaspoonful (tsp)*
Under 24  Under 2  Consult a doctor
24 to 35      2 to under 4    5 mL (1 tsp)  
36 to 47      4 to under 6    7.5 mL (1 1/2 tsp)
48 to 59      6 to under 9   10 mL (2 tsp)
60 to 71  9 to under 11   12.5 mL (2 1/2 tsp) 
72 to 95  11 to under 12   15 mL (3 tsp)

* or as directed by a doctor

Questions?

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Other Information (Other information)
  • Each 5 mL contains: Sodium 3 mg
  • If dispensed, dispense in a tight, light resistant container with a child-resistant cap.
  • Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)
Inactive Ingredients (Inactive ingredients)

Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution, Sucralose.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ONCOR PHARMACEUTICALS

NDC 83720- 500-16

Pain and

Fever Relief

kids

Acetaminophen

Liquid 160 mg / 5 mL

Alcohol Free

Sugar Free

Aspirin Free

Ibuprofen Free

Cherry Flavor

16 fl. oz. - 473 mL

ONCOR PHARMACEUTICALS

NDC 83720- 500-16

Pain and

Fever Relief

kids

Acetaminophen

Liquid 160 mg / 5 mL

Alcohol Free

Sugar Free

Aspirin Free

Ibuprofen Free

Cherry Flavor

4 fl. oz. - 118 mL

Active Ingredient (in Each 5 Ml Teaspoonful) (Active ingredient (in each 5 mL teaspoonful))

Acetaminophen, USP 160 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:01.234165 · Updated: 2026-03-14T23:08:29.204921