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Arthritis Pain Reliever by AvPAK

Medically reviewed on March 7, 2018

Dosage form: tablet, film coated, extended release
Ingredients: ACETAMINOPHEN 650mg
Labeler: AvPAK
NDC Code: 50268-052

DRUG FACTS

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP, 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

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.

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). 

INACTIVE INGREDIENTS

croscarmellose sodium, D&C red no. 30 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS?

call 1-855-361-3993

Contains No Aspirin

Keep the carton. It contains important information.

0115

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50268-052-15
Acetaminophen Extended-release Tablets USP
Arthritis Pain Relief
650 mg
50 Tablets (5 X 10) Unit Dose

NDC 50268-052-15
Acetaminophen Extended-release Tablets USP
Arthritis Pain Relief
650 mg
50 Tablets (5 X 10) Unit Dose

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN.

Use only as directed.

Manufactured for: AvKARE, Inc.   Pulaski, TN 38478

Mfg. Rev. R0315        AV 02/16 (P)

AvPAK
A PRODUCT OF AvKARE

ARTHRITIS PAIN RELIEVER  
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-052(NDC:51660-333)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM LAURYL SULFATE 
STEARIC ACID 
TITANIUM DIOXIDE 
STARCH, CORN 
PROPYLENE GLYCOL 
POVIDONES 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize19mm
FlavorImprint Codecor116
Contains    
Packaging
#Item CodePackage Description
1NDC:50268-052-1550 BLISTER PACK in 1 BOX, UNIT-DOSE
1NDC:50268-052-111 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620003/07/2016
Labeler - AvPAK (832926666)

 
AvPAK

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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