Pain Relief Extra Strength

Drug Labeling and Warnings

Drug Details [pdf]

PAIN RELIEF EXTRA STRENGTH- acetaminophen capsule, liquid filled 
PuraCap Pharmaceutical LLC

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

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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

  • skin reddening
  • blisters
  • rash

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

  • do not take more than directed (see Overdose warning)

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

  • store at room temperature 15°-30°C (59°-86°F)

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 

 EXTRA STRENGTH PAIN RELIEF

 ACETAMINOPHEN

  Aspirin free

NDC: 51013-107-25

Compare to the active ingredient in TYLENOL® Extra Strength

Pain reliever/Fever reducer

40 Liquid Gels

CVS APAP 500mg 40ct

EXTRA STRENGTH PAIN RELIEF

ACETAMINOPHEN

Aspirin free

NDC: 51013-107-26

Compare to the active ingredient in TYLENOL® Extra Strength

Pain reliever/Fever reducer

80 Liquid Gels

CVS APAP 500mg 80ct

PAIN RELIEF EXTRA STRENGTH 
acetaminophen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51013-107
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 GLYCOLS (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: 51013-107-2540 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/20/201406/30/2019
2NDC: 51013-107-2680 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/20/201406/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/20/201406/30/2019
Labeler - PuraCap Pharmaceutical LLC (962106329)
Registrant - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. (421293287)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-107) , analysis(51013-107)

Revised: 12/2017
Document Id: 60e1b2fb-646b-badf-e053-2a91aa0a9a55
Set id: 291ee15a-316b-4f56-92dd-c994dd8155ab
Version: 4
Effective Time: 20171221