Acetaminophen

Acetaminophen
SPL v6
SPL
SPL Set ID ace5ebac-ec11-4c26-b1e3-954b450ee671
Route
ORAL
Published
Effective Date 2023-09-12
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 Sucralose Sodium Benzoate Sodium Citrate, Unspecified Form Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-05

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.

Section 50569-3

Ask a doctor before use if your 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
  • 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)
or as directed by a doctor
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)
Questions?

You may report side effects by calling Westminster M-F (9 a.m. to 5 p.m. EST), at 1-844-221-7294 or FDA at 1-800-FDA-1088.

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.

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 that contain acetaminophen
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)
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

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

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
  • redness or swelling is present
  • any new symptoms appear.

These could be signs of a serious condition.

Ask A Doctor Or Pharmacist Before Use

if your child is taking the blood thinning drug warfarin.

Active Ingredient (in Each 5 Ml Teaspoonful)

Acetaminophen, USP 160 mg

Principal Display Panel 118 Ml Bottle Label

NDC 69367-323-04

Children's

Acetaminophen

Liquid

160 mg/5 mL

Pain Reliever / Fever Reducer

Sugar Free / Alcohol Free

Aspirin Free

CHERRY FLAVOR

4 fl. oz. (118 mL)

Westminster

Pharmaceuticals


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.

Section 50569-3 (50569-3)

Ask a doctor before use if your 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
  • 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)
or as directed by a doctor
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)
Questions?

You may report side effects by calling Westminster M-F (9 a.m. to 5 p.m. EST), at 1-844-221-7294 or FDA at 1-800-FDA-1088.

Allergy Alert (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.

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 that contain acetaminophen
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)
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)

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

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
  • redness or swelling is present
  • any new symptoms appear.

These could be signs of a serious condition.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

if your child is taking the blood thinning drug warfarin.

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

Acetaminophen, USP 160 mg

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

NDC 69367-323-04

Children's

Acetaminophen

Liquid

160 mg/5 mL

Pain Reliever / Fever Reducer

Sugar Free / Alcohol Free

Aspirin Free

CHERRY FLAVOR

4 fl. oz. (118 mL)

Westminster

Pharmaceuticals


Advanced Ingredient Data


Raw Label Data

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