REGULAR STRENGTH PAIN RELIEVER

Set ID
4388e547-7d74-4b1d-83b2-674a49ee38a1
Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:41:35

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

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

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 you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drugs 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.

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.

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

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

Directions And Dosage

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

Other information

store between 20-25°C (68-77°F) do not use if carton is opened or neck wrap or foil inner seal imprinted with "SAFETY SEAL" is broken or missing

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

SPRIIT 360 REGULAR STRENGTH PAIN RELIEVER ACETAMINOPHEN 325 mg PAIN RELIEVER / FEVER REDUCER 100 TABLETS

NDC Codes

Ingredients

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

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Warnings

Liver warning

WARNINGS SECTION

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 you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drugs 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.

Do not use

OTC - DO NOT USE SECTION

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 you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

SPL UNCLASSIFIED SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

store between 20-25°C (68-77°F) do not use if carton is opened or neck wrap or foil inner seal imprinted with "SAFETY SEAL" is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPRIIT 360 REGULAR STRENGTH PAIN RELIEVER ACETAMINOPHEN 325 mg PAIN RELIEVER / FEVER REDUCER 100 TABLETS

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc28db95c4-791e-f01d-e063-6394a90a4e8b.xml2024-12-11
otc0c031bc3-42c4-dd6b-e063-6294a90ae2c8.xml2023-12-09
otcee8ee0ab-fc77-dc57-e053-2a95a90adf2d.xml2022-11-30
otcbf512fd3-9f93-3fc4-e053-2995a90af9dc.xml2021-04-07
otcRS PAIN RELIEVER.jpg2021-04-07