BERKLEY AND JENSEN ACETAMINOPHEN- acetaminophen tablet, film coated, extended release 
BJWC

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BJWC Acetaminophen Drug Facts

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

•
temporarily relieves minor aches and pains due to:
•
arthritis
•
the common cold
•
headache
•
toothache
•
muscular aches
•
backache
•
menstrual cramps
•
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

Do not use

•
if you are allergic to acetaminophen
•
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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 for more than 10 days
•
fever gets worse or lasts for 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: Taking more than the recommended dose (overdose) may cause liver damage. 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 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).

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-934-1204

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT OF TYLENOL® ARTHRITIS PAIN

Arthritis Pain Relief†

Acetaminophen

Extended-Release Tablets, 650 mg

Pain Reliever-Fever Reducer

Lasts up to 8 Hours

See New Warnings Information

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

†For the Temporary Relief of Minor Arthritis Pain

ACTUAL SIZE

650 mg Each

*Capsule-shaped tablets

Acetaminophen Label Image

Acetaminophen Label Image

Acetaminophen Label Image

BERKLEY AND JENSEN ACETAMINOPHEN 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-544
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
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 400 (UNII: B697894SGQ)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (caplet) Size19mm
FlavorImprint Code L544
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68391-544-87300 in 1 BOTTLE; Type 0: Not a Combination Product04/28/200812/14/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07507704/28/200812/14/2016
Labeler - BJWC (159082692)

Revised: 11/2017
Document Id: ec4a5902-97bd-43ee-8bff-46cc3f9eff83
Set id: c0c4d567-4d3a-4eef-bd90-6e5b01f256ea
Version: 3
Effective Time: 20171118
 
BJWC