ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release 
Bryant Ranch Prepack

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Arthritis Pain Relief

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 haveliver disease.

Ask a doctor or pharmacist before use if you aretaking 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

  • store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
  • see end panel for batch number and expiration date
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive ingredients

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

Questions?

call 1-800-406-7984

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

HOW SUPPLIED

NDC: 71335-0524-1: 30 Tablets in a BOTTLE

NDC: 71335-0524-2: 100 Tablets in a BOTTLE

NDC: 71335-0524-3: 50 Tablets in a BOTTLE

NDC: 71335-0524-4: 60 Tablets in a BOTTLE

NDC: 71335-0524-6: 19 Tablets in a BOTTLE

NDC: 71335-0524-5: 120 Tablets in a BOTTLE

Acetaminophen ER 650mg Tablet

Label
ARTHRITIS PAIN RELIEVER 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0524(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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (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)  
CROSPOVIDONE (UNII: 2S7830E561)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize19mm
FlavorImprint Code cor116
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-0524-130 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2022
2NDC:71335-0524-2100 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2022
3NDC:71335-0524-350 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2022
4NDC:71335-0524-460 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2022
5NDC:71335-0524-619 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2022
6NDC:71335-0524-5120 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620004/30/2002
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327repack(71335-0524) , relabel(71335-0524)

Revised: 1/2024
Document Id: 0ea71997-4939-a72e-e063-6294a90a52da
Set id: fb4e9b90-f736-4b30-98d4-980b7468d55a
Version: 8
Effective Time: 20240111
 
Bryant Ranch Prepack