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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
BJWC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer
Authorization status:
Abbreviated New Drug Application
Authorization number:
68391-669-79, 68391-669-87

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

extended release

BJWC

----------

BJWC Arthritis Pain Relief Drug Facts

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpos e

Pain reliever/fever reducer

Us es

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

Ask a doctor before use if you have

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

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

skin reddening

blisters

rash

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

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

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

under 18 years of age

Other information

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?

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

do not take more than directed (see overdose warning)

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

ask a doctor

store at 20-25 C (68-77 F)

meets the requirements of USP Dissolution Test 2

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

BERKLEY AND JENSEN ARTHRITIS PAIN RELIEF

acetaminophen tablet, film coated, extended release

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 39 1-6 6 9

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

6 50 mg

BJWC

Inactive Ingredients

Ingredient Name

Stre ng th

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

19 mm

Flavor

Imprint Code

L544

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 39 1-6 6 9 -8 7

30 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 5/0 8 /20 14

2

NDC:6 8 39 1-6 6 9 -79

40 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/29 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 750 77

0 5/0 8 /20 14

Labeler -

BJWC (159082692)

Revised: 11/2019

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