8 HOUR PAIN RELIEF - acetaminophen tablet, film coated, extended release 
HyVee Inc

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Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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

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

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

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

SEE NEW WARNINGS INFORMATION

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 MUSCLE ACHES AND PAIN

*Take only as directed

650 mg EACH

*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 2


8 HOUR PAIN RELIEF 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-217
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
COLLOIDAL SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 80 
POVIDONE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScore no score
ShapeCAPSULESize19mm
FlavorImprint Code L217
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:42507-217-711 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
150 TABLET, FILM COATED, EXTENDED RELEASE ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (42507-217-71)
2NDC:42507-217-781 BOTTLE ( BOTTLE) in 1 CARTONcontains a BOTTLE
2100 TABLET, FILM COATED, EXTENDED RELEASE ( TABLET) in 1 BOTTLEThis package is contained within the CARTON (42507-217-78)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07507709/23/2005

Labeler - HyVee Inc (006925671)

Revised: 01/2010 HyVee Inc