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Principal Display Panel
SPL v5
SPL
SPL Set ID e3058c3c-6a73-4dc0-820f-c0c036ef1d19
Route
ORAL
Published
Effective Date 2020-10-08
Document Type 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

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