EXTRA STRENGTH PAIN RELIEF- acetaminophen capsule, liquid filled 
Chain Drug Marketing Association 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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Extra Strength Pain Relief

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

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 of age 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 under 12 years of age

     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: 248-449-9300

PRINCIPAL DISPLAY PANEL - 40ct

Extra Strength Pain Relief

Acetaminophen, 500mg 40 Liquid Gels

NDC 63868-863-40

*Compare to the active ingredient in TYLENOL® Extra Strength

Bottle Front - 40ct

Bottle Back - 40ct

PRINCIPAL DISPLAY PANEL - 80ct

Extra Strength Pain Relief

Acetaminophen, 500mg 80 Liquid Gels

NDC 63868-863-80

*Compare to the active ingredient in TYLENOL® Extra Strength

Bottle Front - 80ct

Bottle Back - 80ct

EXTRA STRENGTH PAIN RELIEF 
acetaminophen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-863
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) Scoreno score
Shapecapsule (oblong) Size27mm
FlavorImprint Code PC24
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-863-4040 in 1 BOTTLE; Type 0: Not a Combination Product07/22/2016
2NDC:63868-863-8080 in 1 BOTTLE; Type 0: Not a Combination Product07/22/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/22/2016
Labeler - Chain Drug Marketing Association Inc. (011920774)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(63868-863) , analysis(63868-863)

Revised: 12/2019
Document Id: 7ea5e3ae-a250-49d0-9fc8-b78e25b3114c
Set id: 8e96f75c-de8e-472a-aadb-3767dc64dfc6
Version: 2
Effective Time: 20191230
 
Chain Drug Marketing Association Inc.