340R-TCL 49483-340 APAP 325 MG

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs
Effective date
2024-06-12
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:17:07

Key Label Information

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Acetaminophen 325 mg

OTC - PURPOSE SECTION

Purpose Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

Uses 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

Warnings

WARNINGS SECTION

Warnings Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if: adult takes more than 4,000 mg of acetaminophen in 24 hours. child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 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.

OTC - DO NOT USE SECTION

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 ingredients in this product

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions do not take more than directed See overdose warning adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a doctor children under 6 years ask a doctor

Other Label Information

INACTIVE INGREDIENT SECTION

Inactive ingredients povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain this ingredient

PRINCIPAL DISPLAY PANEL

NDC Codes

Ingredients

Complete SPL Sections

DRUG FACTS

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Acetaminophen 325 mg

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Uses 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

WARNINGS SECTION

WARNINGS SECTION

Warnings Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if: adult takes more than 4,000 mg of acetaminophen in 24 hours. child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 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.

OTC - DO NOT USE SECTION

OTC - DO NOT USE SECTION

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 ingredients in this product

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the user has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

OTC - STOP USE SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults pain gets worse or lasts more than 5 days in children under 12 years 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions do not take more than directed See overdose warning adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a doctor children under 6 years ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Other information SODIUM FREE store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Inactive ingredients povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain this ingredient

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Questions or comments? call 1-877-290-4008 Manufactured by: Time-Cap Labs, Inc., 7 Michael Avenue, Farmingdale, NY 11735 340R 1022

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

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