SPL v4
SPL
SPL Set ID 4d01c9ee-26be-4cdd-b52d-7fa344c1933a
Route
ORAL
Published
Effective Date 2024-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-18

Description

(in each 5 mL = 1 teaspoonful) Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer


Medication Information

Purpose

Pain Reliever/Fever Reducer

Description

(in each 5 mL = 1 teaspoonful) Acetaminophen 160 mg

Uses

temporarily ■ reduces fever

■ relieves minor aches and pains due to:

■ the common cold ■ flu ■ headache ■ sore throat

■ toothache

Section 50568-5

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

Section 50569-3

Ask a doctor before use if  your child hasliver disease

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
  • shake well before using
  • mL = milliliter; tsp = teaspoonful
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor.

Dosing Chart

Weight (lb) Age (yr) Dose (mL or tsp)*
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 5 mL  (1 tsp)
36-47 lbs 4-5 years 7.5 mL  (1 1⁄2 tsp)
48-59 lbs 6-8 years

10 mL   (2 tsp)

60-71 lbs 9-10 years 12.5 mL  (2 1⁄2 tsp)
72-95 lbs 11 years

15 mL  (3 tsp)

*or as directed by a doctor

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 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.

Product Label

Active Ingredient

(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Other Information
  • Keep carton for full directions for use
  • each 5 mL (1 tsp) contains: sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate
Inactive Ingredients

anhydrous citric acid, butylparaben, FD&C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and

carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

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

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 for adults as well as for children even if you do not notice any signs or symptoms.


Structured Label Content

Uses

temporarily ■ reduces fever

■ relieves minor aches and pains due to:

■ the common cold ■ flu ■ headache ■ sore throat

■ toothache

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if  your child hasliver disease

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.

Directions
  • ​this product does not contain directions or complete warnings for adult use
  • shake well before using
  • mL = milliliter; tsp = teaspoonful
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor.

Dosing Chart

Weight (lb) Age (yr) Dose (mL or tsp)*
under 24 under 2 years ask a doctor
24-35 lbs 2-3 years 5 mL  (1 tsp)
36-47 lbs 4-5 years 7.5 mL  (1 1⁄2 tsp)
48-59 lbs 6-8 years

10 mL   (2 tsp)

60-71 lbs 9-10 years 12.5 mL  (2 1⁄2 tsp)
72-95 lbs 11 years

15 mL  (3 tsp)

*or as directed by a doctor

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 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.

Product Label (Product label)

Active Ingredient

(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Other Information (Other information)
  • Keep carton for full directions for use
  • each 5 mL (1 tsp) contains: sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, butylparaben, FD&C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and

carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

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

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 for adults as well as for children even if you do not notice any signs or symptoms.


Advanced Ingredient Data


Raw Label Data

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