Acetaminophen
ecf95a39-7b34-560b-e053-2a95a90af2ac
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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.
Principal Display Panel
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
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.
Principal Display Panel (PRINCIPAL DISPLAY PANEL -)
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
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:00:22.066639 · Updated: 2026-03-14T23:00:46.071932