PAIN RELIEVER EXTRA STRENGTH- acetaminophen capsule 
Hannaford Brothers Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Hannaford Bros. Co. Pain Reliever Extra Strength Drug Facts

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

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

•
more than 8 gelcaps 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

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

•
new symptoms occur
•
redness or swelling is present
•
pain gets worse or lasts for more than 10 days
•
fever gets worse or lasts for more than 3 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. 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 use more than directed (see Liver warning)

adults and children 12

years and over
•
take 2 gelcaps every 6 hours while symptoms last
•
do not take more than 8 gelcaps in 24 hours
•
do not use for more than 10 days unless directed by a doctor

children under 12 years

do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause liver damage

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide

Questions or comments?

1-800-213-9040

Principal Display Panel

See New Warnings Information

Compare to Tylenol® Rapid Release Gels active ingredient

Pain Reliever/Fever Reducer

Acetaminophen

Pain Reliever

Extra Strength

Rapid Release

500 mg each

Pain Reliever Extra Strength Carton Image 1

Pain Reliever Extra Strength Carton Image 1

Pain Reliever Extra Strength Carton Image 2

Pain Reliever Extra Strength Carton Image 1

Pain Reliever Extra Strength Carton Image 2

PAIN RELIEVER  EXTRA STRENGTH
acetaminophen capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41268-046
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Product Characteristics
ColorRED (grey top) Scoreno score
ShapeCAPSULE (tablet) Size19mm
FlavorImprint Code L046
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41268-046-711 in 1 CARTON12/30/200906/04/2012
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:41268-046-781 in 1 CARTON12/30/200906/04/2012
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/30/200906/04/2012
Labeler - Hannaford Brothers Company (006949556)

Revised: 11/2017
Document Id: 9a436431-f4d9-431d-b649-ab0bfb83537e
Set id: 38f62be1-5219-4a7a-9ff1-5e8256a40cc0
Version: 2
Effective Time: 20171121
 
Hannaford Brothers Company