ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release 
AvPAK

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Acetaminophen Extended-release Tablets USP

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

label 1
label 2
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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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize19mm
FlavorImprint Code cor116
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50268-052-1550 in 1 BOX, UNIT-DOSE03/07/2016
1NDC:50268-052-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620003/07/2016
Labeler - AvPAK (832926666)

Revised: 1/2022
Document Id: d5cbb27d-91f9-1acd-e053-2a95a90acd87
Set id: fa9c5660-2e9a-3f2c-ae1e-f77af543e877
Version: 5
Effective Time: 20220117
 
AvPAK