Extra Strength Pain Relief Acetaminophen 500 Mg
95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e
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:
- the common cold
- headache
- backache
- minor pain of arthritis
- muscular aches
- toothache
- premenstrual and menstrual cramps
- temporarily reduces fever
Section 42229-5
Drug Facts
Section 50565-1
KEEP OUT OF REACH OF CHILDREN.
Overdose warning: In case of overdose, get medical help or contact a Poison Control (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 50566-9
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
Section 50568-5
Ask a doctor/pharmacist before use if you are
- taking the blood thinning drug warfarin
Section 50569-3
Ask a doctor before use if you have
- 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.
- If you are allergic to acetaminophen or any of the inactive ingredient in this product.
Section 51945-4
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 60561-8
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.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Directions
- do not take more than directed (see overdose warning)
Adults and children 12 years and over:
- take 2 Caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
Children under 12 Years
- ask a doctor
Other Information
- store at 20º - 25ºC (68º -77ºF)
Inactive Ingredients
Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone k30, Purified water, Sodium Starch Glycolate, Starch Corn, Talc, Titanium Dioxide
Questions Or Comments?
Call 1 (718) 337-8733 or visit: [email protected]
Active Ingredient (in Each Caplet)
Acetaminophen 500 mg
Structured Label Content
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- muscular aches
- toothache
- premenstrual and menstrual cramps
- temporarily reduces fever
Section 42229-5 (42229-5)
Drug Facts
Section 50565-1 (50565-1)
KEEP OUT OF REACH OF CHILDREN.
Overdose warning: In case of overdose, get medical help or contact a Poison Control (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Section 50566-9 (50566-9)
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
Section 50568-5 (50568-5)
Ask a doctor/pharmacist before use if you are
- taking the blood thinning drug warfarin
Section 50569-3 (50569-3)
Ask a doctor before use if you have
- 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.
- If you are allergic to acetaminophen or any of the inactive ingredient in this product.
Section 51945-4 (51945-4)
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 60561-8 (60561-8)
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.
Purpose
Pain reliever/fever reducer
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Directions
- do not take more than directed (see overdose warning)
Adults and children 12 years and over:
- take 2 Caplets every 6 hours while symptoms last
- do not take more than 6 caplets in 24 hours, unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
Children under 12 Years
- ask a doctor
Other Information (Other information)
- store at 20º - 25ºC (68º -77ºF)
Inactive Ingredients (Inactive ingredients)
Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone k30, Purified water, Sodium Starch Glycolate, Starch Corn, Talc, Titanium Dioxide
Questions Or Comments? (Questions or comments?)
Call 1 (718) 337-8733 or visit: [email protected]
Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))
Acetaminophen 500 mg
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:49.868415 · Updated: 2026-03-14T23:11:42.520832