Acetaminophen

Manufacturer
H-E-B | Ranbaxy Pharmaceuticals Inc. | Ohm Laboratories Inc.
Effective date
2014-10-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:55

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. Sever 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 • 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 1-800-406-7984 Contains No Aspirin Keep the carton. It contains important information. MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204 5108051/R0514

PRINCIPAL DISPLAY PANEL

Compare to Tylenol ® Arthritis Pain the active ingredient** H-E-B ® ARTHRITIS PAIN RELIEF acetaminophen Extended-Release Tablets, USP 650 mg Pain Reliever/Fever Reducer Lasts up to 8 hrs • For the Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN See New Warning Use only as directed. 50 CAPLETS* ( * Capsule-Shaped Tablets)

Label Images

APAPGeltabs
APAPGeltabs

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. Sever 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 • 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 1-800-406-7984 Contains No Aspirin Keep the carton. It contains important information. MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204 5108051/R0514

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Tylenol ® Arthritis Pain the active ingredient** H-E-B ® ARTHRITIS PAIN RELIEF acetaminophen Extended-Release Tablets, USP 650 mg Pain Reliever/Fever Reducer Lasts up to 8 hrs • For the Temporary Relief of Minor Arthritis Pain DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN See New Warning Use only as directed. 50 CAPLETS* ( * Capsule-Shaped Tablets)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otca67ea2d8-b415-4468-9e7a-bae4172428a0.xml2014-11-25
otcAPAPGeltabs.jpg2014-11-25