PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet 
SUPERVALU INC.

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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Equaline 44-519

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

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:

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
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • 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 (1-800-222-1222) 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

Other information

Inactive ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide

Questions or comments?

1-877-932-7948

Principal Display Panel

equaline®

compare to the active ingredient in Extra Strength Tylenol® Rapid Release Gels

NDC 41163-519-29

extra strength
pain relief
rapid release
acetaminophen
pain reliever/fever reducer
fast release

actual size
aspirin-free

150gelcaps 500 mg each

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DOES NOT CONTAIN GLUTEN
This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Rapid Release Gels.                                            50844         REV0513E51929

DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA

We're committed to your satisfaction and guarantee the quality of this product.
Contact us at 1-877-932-7948, or www.supervalu-ourownbrands.com.
Please have package available.

Equaline 44-519

Equaline 44-519


PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-519
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
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)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
Product Characteristics
Color RED (red,gray and blue) Score no score
Shape OVAL Size 20mm
Flavor Imprint Code L;5
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41163-519-29 1 in 1 CARTON
1 150 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:41163-519-08 1 in 1 CARTON
2 24 in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:41163-519-12 1 in 1 CARTON
3 100 in 1 BOTTLE; Type 0: Not a Combination Product
4 NDC:41163-519-15 1 in 1 CARTON
4 50 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 05/10/2004
Labeler - SUPERVALU INC. (006961411)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(41163-519)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(41163-519)

Revised: 8/2014
Document Id: 48d46ebc-ca3c-42b7-abd6-f77ea0d5712e
Set id: 363bddf7-0258-4239-8772-4966fbbe3f6b
Version: 7
Effective Time: 20140812
 
SUPERVALU INC.