BERKLEY AND JENSEN ARTHRITIS PAIN RELIEF- acetaminophen tablet, film coated, extended release

Berkley and Jensen Arthritis Pain Relief by

Drug Labeling and Warnings

Berkley and Jensen Arthritis Pain Relief by is a Otc medication manufactured, distributed, or labeled by BJWC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Acetaminophen 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)
• meets the requirements of USP Dissolution Test 2

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-934-1204

Principal Display Panel

Compare to the active ingredient in Tylenol® 8HR Arthritis Pain

ARTHRITIS PAIN RELIEF

ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650mg

PAIN RELIEVER/FEVER REDUCER

FOR THE TEMPORARY RELIEF OF MINOR ARTHRITIS PAIN

ACTUAL SIZE

GLUTEN FREE

400 CAPLETS*

*CAPSULE-SHAPED TABLETS

650 mg EACH

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

INGREDIENTS AND APPEARANCE

BERKLEY AND JENSEN ARTHRITIS PAIN RELIEF 
acetaminophen tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68391-669
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	L544
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68391-669-87	300 in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2014
2	NDC: 68391-669-79	400 in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075077	05/08/2014

Labeler - BJWC (159082692)