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e3058c3c-6a73-4dc0-820f-c0c036ef1d19
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 500 mg
Medication Information
Warnings and Precautions
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 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.
Indications and Usage
• temporarily relieves minor aches and pains due to: • the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches • premenstrual and menstrual cramps • temporarily reduces fever
Dosage and Administration
• 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
Description
Acetaminophen 500 mg
Section 50565-1
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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
• pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present These could be signs of a serious condition.
Section 50568-5
taking the blood thinning drug warfarin
Section 50569-3
liver disease
Section 50570-1
• 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 have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6
carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain one or more of these ingredients
Section 51945-4
Extra Strength Compare to Extra Strength Tylenol ® Caplets active ingredient Acetaminophen Pain Reliever/Fever Reducer For Adults actual size 200 CAPLETS 500 mg Each
Section 53413-1
1-800-719-9260
Section 53414-9
ask a health professional before use.
Section 55105-1
Pain reliever/fever reducer
Section 55106-9
Acetaminophen 500 mg
Structured Label Content
Indications and Usage (34067-9)
• temporarily relieves minor aches and pains due to: • the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches • premenstrual and menstrual cramps • temporarily reduces fever
Dosage and Administration (34068-7)
• 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
Warnings and Precautions (34071-1)
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 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.
Section 50565-1 (50565-1)
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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)
• pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present These could be signs of a serious condition.
Section 50568-5 (50568-5)
taking the blood thinning drug warfarin
Section 50569-3 (50569-3)
liver disease
Section 50570-1 (50570-1)
• 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 have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6 (51727-6)
carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain one or more of these ingredients
Section 51945-4 (51945-4)
Extra Strength Compare to Extra Strength Tylenol ® Caplets active ingredient Acetaminophen Pain Reliever/Fever Reducer For Adults actual size 200 CAPLETS 500 mg Each
Section 53413-1 (53413-1)
1-800-719-9260
Section 53414-9 (53414-9)
ask a health professional before use.
Section 55105-1 (55105-1)
Pain reliever/fever reducer
Section 55106-9 (55106-9)
Acetaminophen 500 mg
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:03:46.116420 · Updated: 2026-02-15T12:03:45.686569