Acetaminophen

Manufacturer
Family Dollar Services, Inc. | Ohm Laboratories Inc.
Effective date
2020-07-06
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:20:19

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

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

Other information

• 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

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

Questions?

call 1-800-406-7984

PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton

FAMILY wellness™ COMPARE TO TYLENOL ® ARTHRITIS PAIN* EASY TO OPEN BOTTLE Use only as directed. NDC 55319-333-01 ARTHRITIS Pain Relief Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever/Fever Reducer • For the Temporary Relief of Minor Arthritis Pain Lasts up to 8 Hours DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN ACTUAL SIZE THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN 100% SATISFACTION OR YOUR MONEY BACK GUARANTEED 100 CAPLETS* (*Capsule-Shaped Tablets)

Label Images

acetaminophen-01
acetaminophen-01

NDC Codes

Ingredients

Complete SPL Sections

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

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

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

STORAGE AND HANDLING 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

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

Questions?

OTC - QUESTIONS SECTION

call 1-800-406-7984

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: MIDWOOD BRANDS, LLC 500 Volvo Parkway, Chesapeake, VA 23320 USA

PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAMILY wellness™ COMPARE TO TYLENOL ® ARTHRITIS PAIN* EASY TO OPEN BOTTLE Use only as directed. NDC 55319-333-01 ARTHRITIS Pain Relief Acetaminophen Extended-release Tablets USP, 650 mg Pain Reliever/Fever Reducer • For the Temporary Relief of Minor Arthritis Pain Lasts up to 8 Hours DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN ACTUAL SIZE THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN 100% SATISFACTION OR YOUR MONEY BACK GUARANTEED 100 CAPLETS* (*Capsule-Shaped Tablets)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML bytes
33061

Legacy File Index

FolderFileDate
otc9f6c1828-d7a7-489c-91c4-fd6f4faf2dc8.xml2020-07-07
otc827f5f89-2661-4fa7-b494-2661ed8eae4a.xml2020-01-22
otc2613c219-41db-43ef-8f0f-97b06c8f05b1.xml2019-08-27
otcacetaminophen-01.jpg2019-08-27