Extra Strength Pain Relief Acetaminophen 500 Mg
e817bc4a-43ef-4126-b903-aabd1390cd0c
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 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
Pregelatinzed starch, Polyvinyl pyrrolidone, stearic acid powder, microcrystalline cellulose, magnesium stearate, Hypromellose-5, Hypromellose-15, polyethlene glycol 400, titanium dioxide, talc
Questions Or Comments?
Call 1 (732) 994-2808 or email [email protected]
Active Ingredient (in Each Caplet)
Acetaminophen 500 mg
Ndc 72090 038 01 (500ct Hdpe Bottle)
Ndc 72090 038 02 (300ct Hdpe Bottle)
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 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)
Pregelatinzed starch, Polyvinyl pyrrolidone, stearic acid powder, microcrystalline cellulose, magnesium stearate, Hypromellose-5, Hypromellose-15, polyethlene glycol 400, titanium dioxide, talc
Questions Or Comments? (Questions or comments?)
Call 1 (732) 994-2808 or email [email protected]
Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))
Acetaminophen 500 mg
Ndc 72090 038 01 (500ct Hdpe Bottle) (NDC 72090-038-01 (500ct HDPE Bottle))
Ndc 72090 038 02 (300ct Hdpe Bottle) (NDC 72090-038-02 (300ct HDPE Bottle))
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:17.157188 · Updated: 2026-03-14T23:06:51.816479