Your browser does not support JavaScript! ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [HYVEE INC]
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RxNorm Names

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


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

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

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

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
•
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

•
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, 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

Compare to Tylenol® Arthritis Pain active ingredient

Temporary, Minor

ARTHRITIS PAIN RELIEF

Acetaminophen Extended - Release Tablets, 650 mg

Pain Reliever / Fever Reducer

650 mg EACH

*Capsule-Shaped Tablets

Arthritis Pain Relief Carton Image 1
Arthritis Pain Relief Carton Image 2
ARTHRITIS PAIN RELIEF 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-544
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
POVIDONES 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (caplet) Size19mm
FlavorImprint Code L544
Contains    
Packaging
#Item CodePackage Description
1NDC:42507-544-711 in 1 CARTON
150 in 1 BOTTLE
2NDC:42507-544-781 in 1 CARTON
2100 in 1 BOTTLE
3NDC:42507-544-851 in 1 CARTON
3250 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07507711/06/2005
Labeler - HyVee Inc (006925671)

Revised: 02/2013
Document Id: 31faafb2-6593-484c-affc-6221c02ecf90
Set id: 02dd52f1-b110-4753-9703-6c78b712a946
Version: 2
Effective Time: 20130225
 
HyVee Inc

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