ARTHRITIS PAIN RELIEF- acetaminophen tablet, extended release 
CHAIN DRUG CONSORTIUM

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1200A-PRV-2020-0902

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

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, unless directed by a doctor
  • 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

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

1-844-705-4384

PRINCIPAL DISPLAY PANEL

Premier Value®

COMPARE TO THE ACTIVE INGREDIENT IN TYLENOL® 8HR ARTHRITIS PAIN†

For the temporary relief of minor arthritis pain

8 HOUR

Arthritis Pain Relief

ACETAMINOPHEN EXTENDED RELEASE TABLETS, 650MG

PAIN RELIEVER/FEVER REDUCER

50 CAPLETS**-650 MG EACH

**Capsule-shaped bi-layer tablets

image description

ARTHRITIS PAIN RELIEF 
acetaminophen tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-303
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code G650
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-303-501 in 1 CARTON08/01/2020
150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:68016-303-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21154408/01/2020
Labeler - CHAIN DRUG CONSORTIUM (101668460)

Revised: 9/2020
Document Id: af0c4e30-d36d-6243-e053-2995a90a49d1
Set id: 778a15d5-3fa4-4386-8afb-751f4537c10d
Version: 2
Effective Time: 20200911
 
CHAIN DRUG CONSORTIUM