340R Timely 49483-340 Acetaminophen 325 mg Tablets

Set ID
c193dbc0-cc80-4a7c-aa29-457a20edf835
Manufacturer
TIME CAP LABS INC
Effective date
2025-02-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:54:51

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: headache muscular aches backache minor pain of arthritis the common cold toothache 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

NDC Codes

Ingredients

NameUNIIKind
POVIDONEFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB

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: headache muscular aches backache minor pain of arthritis the common cold toothache 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

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/c193dbc0-cc80-4a7c-aa29-457a20edf835/2d9fddd5-a3d6-ac0c-e063-6394a90a89bd.xml
XML SHA-256
118105e034d95cc1eb23d9cd06a296baaf6059bb703beca230c7187f891724a7
XML bytes
26331

Legacy File Index

FolderFileDate
otc2d9fddd5-a3d6-ac0c-e063-6394a90a89bd.xml2025-02-12
otc340R-timely 100ct label.jpg2025-02-12
otc340R-Timely-APAP-1000s-label.jpg2023-03-29
otc340R-Timely-APAP-100s-label.jpg2023-03-29
otcf7f6569d-0d88-0aa4-e053-6394a90a71be.xml2023-03-29
otcAcetaminophen Tablet 325 mg-1000ct-Label.jpg2021-05-01
otcAcetaminophen Tablet 325 mg-100ct-Label.jpg2021-05-01
otcc117745d-768c-9b1e-e053-2a95a90a0c82.xml2021-05-01
otc340R TCL 100CT .jpg2019-09-14
otc927096a6-f9fa-d33a-e053-2a95a90a05c9.xml2019-09-14