Extra Strength Pain Reliever

Extra Strength Pain Reliever

Drug Labeling and Warnings

Drug Details

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EXTRA STRENGTH PAIN RELIEVER- 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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Extra Strength Pain Reliever

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 under 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 sorbitan solution and white edible ink

Questions or Comments?

Call : 1-888-309-9030

PRINCIPAL DISPLAY PANEL

DG Extra Strength Pain Reliever 20 Softgels

Acetaminophen 500mg

NDC: 51013-172-15

*Compare to the active ingredient in TYLENOL® Extra Strength

DG Extra Strength Pain Reliever 20ct-Front

DG Extra Strength Pain Reliever 20ct-Back

DG Extra Strength Pain Reliever 20ct-Front

DG Extra Strength Pain Reliever 20ct-Back

DG Extra Strength Pain Reliever 40 Softgels

Acetaminophen 500mg

NDC: 51013-172-25

*Compare to the active ingredient in TYLENOL® Extra Strength

DG Extra Strength Pain Reliever 40ct-Front

DG Extra Strength Pain Reliever 40ct-Back

DG Extra Strength Pain Reliever 40ct-Front
DG Extra Strength Pain Reliever 40ct-Back

DG Extra Strength Pain Reliever 24 Softgels

Acetaminophen 500mg

NDC: 51013-172-43

*Compare to the active ingredient in TYLENOL® Extra Strength

DG Extra Strength Pain Reliever 24ct-Front

DG Extra Strength Pain Reliever 24ct-Back

EXTRA STRENGTH PAIN RELIEVER 
acetaminophen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51013-172
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)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
Colorred (clear) Scoreno score
Shapecapsule (oblong) Size27mm
FlavorImprint Code PC24
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51013-172-1520 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2016
2NDC: 51013-172-2540 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2016
3NDC: 51013-172-4324 in 1 BOTTLE; Type 0: Not a Combination Product08/22/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/08/2016
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-172) , analysis(51013-172)

Revised: 8/2017
 
PuraCap Pharmaceutical LLC


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