ACETAMINOPHEN 8 HOUR- acetaminophen tablet, film coated, extended release 
Supervalu Inc.

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Drug Facts

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP, 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

  • 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 are allergic to acetaminophen or any of the inactive ingredients in this product.

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.

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

OTHER INFORMATION

INACTIVE INGREDIENTS

Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS?

Call 1-877-932-7948

PRINCIPAL DISPLAY PANEL

equaline®

compare to Tylenol®8 Hour active ingredient*

NDC 41163-336-01

use only as directed

lasts up to 8 hours

acetaminophen extended-release tablets, USP 650 mg

100 caplets**

pain reliever/fever reducer

650 mg each

for up to 8 hour relief of minor muscle aches and pain

(**capsule-shaped tablets)

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

DISTRIBUTED BY SUPERVALU INC.

5098570/R1012

This is the 100 count bottle carton label for Equaline acetaminophen (8 hour) extended-release tablets, USP 650 mg.
ACETAMINOPHEN 8 HOUR 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-336
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (Capsule Shaped) Size19mm
FlavorImprint Code cor116
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-336-011 in 1 CARTON
1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620008/13/2013
Labeler - Supervalu Inc. (006961411)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(41163-336)

Revised: 9/2013
Document Id: 858cc5c1-fa49-4d6b-98b4-608d507d03a2
Set id: 80c990c4-53f4-4102-b99b-f19bc895e5cb
Version: 1
Effective Time: 20130905
 
Supervalu Inc.