ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release 
American Health Packaging

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Acetaminophen Extended-Release Tablets, USP
Pain Reliever/Fever Reducer
8277725/0121

Drug Facts

Active ingredient (in each caplet)
Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

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

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

Inactive ingredients

crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

Questions?

Contains No Aspirin

PACKAGING INFORMATION
American Health Packaging unit dose blisters contain drug product from Ohm Laboratories Inc. as follows:
(650 mg / 30 UD) NDC 68084-777-25 packaged from NDC 51660-333

Distributed by:
American Health Packaging
Columbus, OH 43217

8277725/0121

Principal Display Panel – Carton – 650 mg

650 mg Acetaminophen Extended-release Tablets Carton

NDC 68084- 777-25

Acetaminophen
Extended-release Tablets, USP
Pain Reliever/Fever Reducer

650 mg

30 Tablets (5 x 6)

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN.

Drug Facts

Active Ingredient                 Purpose
(in each caplet)
Acetaminophen USP, 650 mg ................. Pain reliever/fever reducer

Uses
See package insert for complete Drug Facts information.

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.

Keep out of reach of children.

See package insert for additional Drug Facts warnings.

Directions
• do not take more than directed, see package insert for
overdose warning and complete Drug Facts information.

Other Information • store at 20° to 25°C (68° to 77°F).

Avoid excessive heat 40°C (104°F). • FOR YOUR
PROTECTION: Do not use product if blister is torn or broken.

Contains No Aspirin

The drug product contained in this package is
from NDC # 51660-333, Ohm Laboratories Inc.

Distributed by: American Health Packaging
2550 John Glenn Avenue, Suite A
Columbus, OH 43217

077725
0277725/0222

Principal Display Panel – Blister – 650 mg

650 mg Acetaminophen Extended-release Tablet Blister

Acetaminophen
Extended-release
Tablet, USP
Pain Reliever/
Fever Reducer

650 mg

ARTHRITIS PAIN RELIEVER 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68084-777(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
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (Capsule Shaped) Size19mm
FlavorImprint Code cor116
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68084-777-2530 in 1 BOX, UNIT-DOSE08/18/2014
1NDC:68084-777-951 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620008/18/2014
Labeler - American Health Packaging (929561009)
Establishment
NameAddressID/FEIBusiness Operations
American Health Packaging929561009repack(68084-777)

Revised: 6/2022
Document Id: e0e00d71-fc23-d450-e053-2a95a90a4f7a
Set id: ac5b24a4-39a8-4c8a-b293-5f59966fb444
Version: 7
Effective Time: 20220607
 
American Health Packaging