Acetaminophen

Manufacturer
Medline Industries, LP
Effective date
2026-04-10
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:53:25

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each caplet)

Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

Uses

Uses

temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever

Warnings

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount 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.

Directions And Dosage

Directions

Do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor

Other Label Information

Inactive ingredients

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

Questions?

Call toll free 1-800-MEDLINE (633-5463) Monday-Friday 9AM-5PM CST

Package Label

Label Images

53329-643_V1 RG22OHM
53329-643_V1 RG22OHM

NDC Codes

Ingredients

Complete SPL Sections

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP, 650 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor

Other information

SPL UNCLASSIFIED SECTION

store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F). see end panel for batch number and expiration date TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call toll free 1-800-MEDLINE (633-5463) Monday-Friday 9AM-5PM CST

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA with domestic and foreign materials www.medline.com/www.curad.com 1-800-MEDLINE (633-5463) REF: OTC33350N V1 RG22OHM

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML bytes
27509

Legacy File Index

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otc2a765d75-80f7-b3f5-e063-6294a90ac299.xml2025-01-01
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otc8b07674a-cd13-46ec-9f97-a1a873de2feb.xml2020-07-09
otc53329-643_OTC33350N_Bottle.jpg2019-12-19
otc53329-643_OTC33350N_Box.jpg2019-12-19
otc70ab8bbe-150b-7ecf-e053-2991aa0a82c0.xml2019-12-19
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otcAPAPArthritis.jpg2013-03-22