BERLEY AND JENSEN PAIN RELIEF- acetaminophen tablet, film coated 
BJWC

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BJWC Pain Relief Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
the common cold
minor pain of arthritis
headache
backache
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
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 have ever had an allergic reaction to this product or any of its ingredients

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

new symptoms occur
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
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 and children 12 years and over

take 2 caplets every 6 hours while symptoms last
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

children under 12 years

ask a doctor

Other information

store at 20-25°C (68-77°F)
do not use if printed seal under cap is broken or missing

Inactive ingredients

croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, mica-based pearlescent pigment, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid

Questions or comments?

1-800-934-1204

Package/Label Principal Display Panel

Compare to the active ingredient in Tylenol® Extra Strength Rapid Release Gels

berkley jensen®

EXTRA STRENGTH

RAPID RELEASE

PAIN RELIEF

ACETAMIOPHEN

PAIN RELIEVER/FEVER REDUCER

FOR ADULTS

FAST RELIEF

400 CAPLETS | 500 mg EACH

ACTUAL SIZE

pain relief-image
BERLEY AND JENSEN PAIN RELIEF 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorREDScoreno score
ShapeOVALSize18mm
FlavorImprint Code 3S0
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68391-004-79400 in 1 BOTTLE; Type 0: Not a Combination Product11/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01311/30/2015
Labeler - BJWC (159082692)

Revised: 4/2024
Document Id: 13045484-b716-4145-b71d-24f661e88a5d
Set id: d3ee3341-93b8-487c-921e-2892d213efbb
Version: 4
Effective Time: 20240416
 
BJWC