RxNorm Names

Review RxNorm Normal Forms

8 HOUR PAIN RELIEF (acetaminophen) tablet, film coated, extended release
[HyVee Inc]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4e6965c9-b18e-4667-bb5f-92b9b44b024a

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		Abbreviated New Drug Application

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

•: temporarily relieves minor aches and pains due to:
•: muscular aches
•: backache
•: headache
•: minor pain of arthritis
•: temporarily reduces fever

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

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

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

•: pain gets worse or lasts more than 10 days
•: 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.

If pregnant or breast-feeding,

ask a health professional before use.

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.

Directions

•: do not take more than directed (see overdose warning)

adults and children 12 years and over	• 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
children under 12 years	• do not use

Other information

•: store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F).
•: see end panel for lot number and expiration date

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Headache/Backache

Minor Pain of Arthritis

Compare to Tylenol® 8 HR active ingredient

8 HOUR PAIN RELIEF

Acetaminophen Extended-Release Tablets, 650 mg

Pain Reliever-Fever Reducer

FOR UP TO 8 HOUR RELIEF OF MINOR MUSCLE ACHES AND PAIN

Actual Size

650 mg EACH

*capsule-shaped tablets

8 HOUR PAIN RELIEF
acetaminophen tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42507-217
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	650 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
POVIDONES
STEARIC ACID
TITANIUM DIOXIDE

Product Characteristics
Color	RED	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	L217
Contains

Packaging
#	Item Code	Package Description
1	NDC:42507-217-71	1 in 1 CARTON
1		50 in 1 BOTTLE
2	NDC:42507-217-78	1 in 1 CARTON
2		100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075077	09/23/2005

Labeler - HyVee Inc (006925671)

Revised: 12/2012

Document Id: fe4b3e75-56bb-483f-987e-f92d5d6b3fdf

Set id: 4e6965c9-b18e-4667-bb5f-92b9b44b024a

Version: 2

Effective Time: 20121204

HyVee Inc

Daily Med

Current Medication Information

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