Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c3525848-f759-4843-93ec-606c4afcd718
Route
ORAL
Published
Effective Date 2011-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-09-02
Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Uses
temporarily:

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

Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
do not give more than directed (see overdose warning)
  • shake well before using
  • find right dose on chart below. If possible use weight to dose; otherwise, use age.
  • if needed, repeat dose every 4 hours
  • do not give more than 5 times in 24 hours

Weight (lb)

 Age (yr)

 Dose (tsp or mL)
under 24

 under 2

 ask a doctor
24-35

 2-3

 1 tsp or 5 mL
36-47

 4-5

 1 1/2 tsp or 7.5 mL
48-59

 6-8

 2 tsp or 10 mL
60-71

 9-10

 2 1/2 tsp or 12.5 mL
72-95

 11

 3 tsp or 15 mL
Attention:use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Do Not Use
  • with any other product containing acetaminophen

Package Label

Children's Non-Aspirin

Other Information
  • each teaspoon contains: sodium 1 mg
  • do not use if bottle wrap, or foil inner seal imprinted "SEALED for YOUR PROTECTION" is broken or missing

  • store between 20-25°C (68-77°F)
  • see bottom panel for lot number and expiration date

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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Inactive Ingredients

propylparaben, carboxymethylcellulose sodium, citric acid, corn syrup, FD and C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, sucrose, xanthan gum

Stop Use and Ask A Doctor If
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 5 days
  • fever gets worse or lasts for more than 3 days

Keep Out of Reach of Children.

Enter section text here

Active Ingredient (in Each 5 Ml = 1 Teaspoon)



Acetaminophen 160 mg

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

Warnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
do not give more than directed (see overdose warning)
  • shake well before using
  • find right dose on chart below. If possible use weight to dose; otherwise, use age.
  • if needed, repeat dose every 4 hours
  • do not give more than 5 times in 24 hours

Weight (lb)

 Age (yr)

 Dose (tsp or mL)
under 24

 under 2

 ask a doctor
24-35

 2-3

 1 tsp or 5 mL
36-47

 4-5

 1 1/2 tsp or 7.5 mL
48-59

 6-8

 2 tsp or 10 mL
60-71

 9-10

 2 1/2 tsp or 12.5 mL
72-95

 11

 3 tsp or 15 mL
Attention:use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Do Not Use (Do not use)
  • with any other product containing acetaminophen

Package Label (Package label)

Children's Non-Aspirin

Other Information (Other information)
  • each teaspoon contains: sodium 1 mg
  • do not use if bottle wrap, or foil inner seal imprinted "SEALED for YOUR PROTECTION" is broken or missing

  • store between 20-25°C (68-77°F)
  • see bottom panel for lot number and expiration date

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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Inactive Ingredients (Inactive ingredients)

propylparaben, carboxymethylcellulose sodium, citric acid, corn syrup, FD and C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, sucrose, xanthan gum

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts for more than 5 days
  • fever gets worse or lasts for more than 3 days

Keep Out of Reach of Children. (Keep out of reach of children.)

Enter section text here

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: 2026-02-15T11:55:20.355097 · Updated: 2026-03-14T22:52:50.897919