SUNMARK 8 HOUR PAIN RELIEF- acetaminophen tablet, film coated, extended release 
McKesson

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McKesson 8 Hour Pain Relief Drug Facts

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Do not use

•
with any other product containing acetaminophen

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.

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. 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 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

children under 12 years
•
do not use

Other information

•
do not use if printed foil under cap is broken or missing
•
store at 20°-25°C (68°-77°F)
•
avoid excessive heat 40°C (104°F)
•
see end panel for lot number and expiration date

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO TYLENOL® 8 HOUR ACTIVE INGREDIENT

8 hour pain relief

Acetaminophen Extended-Release Tablets, 650 mg

Pain reliever & Fever reducer

FOR UP TO 8 HOUR RELIEF OF MINOR MUSCULAR ACHES & PAINS

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

650 mg

*Capsule-shaped tablets

8 Hour Pain Relief Carton Image 1

8 Hour Pain Relief Carton Image 1

8 Hour Pain Relief Carton Image 2

8 Hour Pain Relief Carton Image 1

8 Hour Pain Relief Carton Image 2

SUNMARK 8 HOUR PAIN RELIEF 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-705
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
ColorREDScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code L217
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-705-091 in 1 CARTON08/30/200511/04/2011
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49348-705-101 in 1 CARTON08/30/200511/04/2011
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07507708/30/200511/04/2011
Labeler - McKesson (177667227)

Revised: 11/2017
Document Id: 663d1c2d-f97a-43ab-9b82-25be31d34210
Set id: 2bcb711c-7ac0-4f32-a5e5-b7e802c8a666
Version: 2
Effective Time: 20171116
 
McKesson