PAIN RELIEF EXTRA STRENGTH- acetaminophen capsule, liquid filled 
CVS PHARMACY, 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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Pain Relief Extra Strength

Drug Facts

Active ingredient (in each softgel)

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 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

Adults and children 12 years  and over

  • take 2 softgels every 6 hours while symptoms last
  • do not take more than 6 softgels in 24 hours unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

Children 12 years 

ask a doctor

Other information

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Questions or Comments?

Call toll free 1-855-215-8180

PRINCIPAL DISPLAY PANEL - 40ct Bottle Label

EXTRA STRENGTH PAIN RELIEF

ACETAMINOPHEN 500 mg 40 Liquid Gels

NDC 69842-073-25

Compare to the active ingredient in TYLENOL® Extra Strength

40ct Bottle Label Front

40ct Bottle Label Back

PRINCIPAL DISPLAY PANEL - 80ct Bottle Label

EXTRA STRENGTH PAIN RELIEF

ACETAMINOPHEN 500 mg 80 Liquid Gels

NDC 69842-073-26

Compare to the active ingredient in TYLENOL® Extra Strength

80ct Bottle Label Front

80ct Bottle Label Back

PAIN RELIEF EXTRA STRENGTH 
acetaminophen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-073
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorred (Clear Red) Scoreno score
ShapeCAPSULE (oblong) Size24mm
FlavorImprint Code PC24
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-073-2540 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/14/2016
2NDC:69842-073-2680 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/14/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/14/2016
Labeler - CVS PHARMACY, INC. (062312574)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287MANUFACTURE(69842-073) , ANALYSIS(69842-073)

Revised: 11/2019
Document Id: 8911d415-855f-46c1-af23-1544f1d89c71
Set id: b98ba5fd-469b-4e4e-9a63-7765483b1d3e
Version: 2
Effective Time: 20191121
 
CVS PHARMACY, INC.