Acetaminophen

Acetaminophen
SPL v2
SPL
SPL Set ID 402c8563-b14b-453f-80bc-4275f1c73702
Route
ORAL
Published
Effective Date 2023-12-01
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 Sodium Benzoate Trisodium Citrate Dihydrate Saccharin Sodium Sorbitol

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

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • arthritis
  • the common cold
  • toothache
  • menstrual cramps
  • reduces 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 even if you do not notice any signs or symptoms.

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.

  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions

Do not exceed recommended dosage.

Questions?

You may report side effects by calling Westminster M-F (9 a.m. to 5 p.m. EST), at 1-844-7294 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 you take:

  • more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Other Information

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)

Overdose Warnings

Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage.

  • adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 mL) in 24 hours
  • children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.
Inactive Ingredients

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

Ask A Doctor Before Use

if you have health issues especially liver disease.

Stop Use and Ask A Doctor If
  • new symptoms occur such as rash, hives, itching or hoarseness
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • symptoms do not improve

These could be signs of a serious condition.

Ask A Doctor Or Pharmacist Before Use

if you are taking other drugs, including the blood thinner warfarin.

Active Ingredient (in Each 5 Ml Teaspoonful)

Acetaminophen, USP 160 mg

Principal Display Panel – 4 Fl. Oz. (118 Ml) Bottle Label

NDC 71205-730-04

Acetaminophen

Liquid

160 mg/5 mL

Pain Reliever / Fever Reducer

Sugar Free / Alcohol Free

Aspirin Free

CHERRY FLAVOR

4 fl. oz. (118 mL)


Structured Label Content

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • arthritis
  • the common cold
  • toothache
  • menstrual cramps
  • reduces 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 even if you do not notice any signs or symptoms.

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.

  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Pain reliever/fever reducer

Directions

Do not exceed recommended dosage.

Questions?

You may report side effects by calling Westminster M-F (9 a.m. to 5 p.m. EST), at 1-844-7294 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 you take:

  • more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Other Information (Other information)

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)

Overdose Warnings

Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage.

  • adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 mL) in 24 hours
  • children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.
Inactive Ingredients (Inactive ingredients)

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

Ask A Doctor Before Use (Ask a doctor before use)

if you have health issues especially liver disease.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • new symptoms occur such as rash, hives, itching or hoarseness
  • redness or swelling is present
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • symptoms do not improve

These could be signs of a serious condition.

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

if you are taking other drugs, including the blood thinner warfarin.

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

Acetaminophen, USP 160 mg

Principal Display Panel – 4 Fl. Oz. (118 Ml) Bottle Label (PRINCIPAL DISPLAY PANEL – 4 fl. oz. (118 mL) Bottle Label)

NDC 71205-730-04

Acetaminophen

Liquid

160 mg/5 mL

Pain Reliever / Fever Reducer

Sugar Free / Alcohol Free

Aspirin Free

CHERRY FLAVOR

4 fl. oz. (118 mL)


Advanced Ingredient Data


Raw Label Data

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