PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet, film coated 
CVS Pharmacy

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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Pain Reliever

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

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 inactives 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

  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur

These could be signs of a serious condition.

If pregnant of breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions or comments?

1-800-426-9391

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Health™                            

Compare to the active ingredient in Extra Strength Tylenol®*

Caplets

 TAMPER EVIDENT: Use Only if This Blister is Intact

NDC 59779-751-03

EXTRA STRENGTH
Pain Relief
ACETAMINOPHEN, 500 mg
Pain reliever / Fever reducer

Aspirin free    

10 CAPLETS   Actual Size

Travel Pack

†This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol®.
50844   REV0617A17503

Distributed by:CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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V-13566

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CVS Health 44-175

CVS Health 44-175

PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-751
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CASTOR OIL (UNII: D5340Y2I9G)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint Code 44;175
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-751-031 in 1 PACKAGE04/02/1993
110 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59779-751-962 in 1 PACKAGE04/02/1993
210 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59779-751-291 in 1 CARTON04/02/199310/20/2015
3150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34304/02/1993
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(59779-751)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837MANUFACTURE(59779-751) , PACK(59779-751)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(59779-751)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(59779-751)

Revised: 8/2019
Document Id: f82498b3-ca6e-4a7f-9854-b9ba1cc8d304
Set id: dcc16dd3-9b6e-42ec-a572-1232054d78e5
Version: 10
Effective Time: 20190821
 
CVS Pharmacy