SUNMARK PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet, coated 
McKesson

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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McKesson Pain Relief 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. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. 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

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

•
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.

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 Liver warning)

adults and children 12

years and over
•
take 2 gelcaps every 6 hours while symptoms last
•
do not take more than 6 gelcaps 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)

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, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO TYLENOL® RAPID RELEASE GELS ACTIVE INGREDIENT

See New Warnings and Directions

pain relief

Extra Strength

Pain reliever & Fever reducer

Fast relief

ACETAMINOPHEN

RAPID RELEASE GELCAPS

500 mg EACH

Pain Relief Carton Image 1

Pain Relief Carton Image 1

Pain Relief Carton Image 2

Pain Relief Carton Image 1

Pain Relief Carton Image 2

SUNMARK PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-892
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)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorRED (grey top) Scoreno score
ShapeCAPSULE (tablet) Size19mm
FlavorImprint Code L046
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-892-101 in 1 CARTON08/04/200908/04/2013
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/04/200908/04/2013
Labeler - McKesson (177667227)

Revised: 11/2017
Document Id: 4bbdcc8d-28b4-428d-9e40-847eea268a96
Set id: d2d183fe-a0dd-47b1-ad55-218b064139a7
Version: 3
Effective Time: 20171117
 
McKesson