Regular Strength Pain Reliever 

Regular Strength Pain Reliever 

Drug Labeling and Warnings

Drug Details

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REGULAR 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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Regular Strength Pain Reliever 

Drug Facts

Active ingredient (in each softgel)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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 the user has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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 4 to 6 hours while symptoms last
  • do not take more than 10 softgels in 24 hours
  • do not use for more than 10 days unless directed by a doctor

children 6-11 years

  • take 1 softgel every 4 to 6 hours while symptoms last
  • do not take more than 5 softgels in 24 hours
  • do not use for more than 5 days unless directed by a doctor

children under 6 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 Regular Strength Pain Reliever  20 Softgels

Acetaminophen 325mg

NDC: 51013-173-15

*Compare to the active ingredient in TYLENOL® Regular Strength

DG Acetaminophen 325mg 20ct

DG Acetaminophen 325mg 20ct

DG Acetaminophen 325mg 20ct

DG Acetaminophen 325mg 20ct

DG Acetaminophen 325mg 20ct

DG Acetaminophen 325mg 20ct

DG Regular Strength Pain Reliever 40 Softgels

Acetaminophen 325mg

NDC: 51013-173-25

*Compare to the active ingredient in TYLENOL® Regular Strength

DG Acetaminophen 325mg 40ct

DG Acetaminophen 325mg 40ct

DG Acetaminophen 325mg 40ct

DG Acetaminophen 325mg 40ct

DG Regular Strength Pain Reliever 24 Softgels

Acetaminophen 325mg

NDC: 51013-173-43

*Compare to the active ingredient in TYLENOL® Regular Strength

DG Acetaminophen 325mg 24ct

DG Acetaminophen 325mg 24ct

DG Acetaminophen 325mg 24ct

REGULAR STRENGTH PAIN RELIEVER 
acetaminophen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51013-173
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 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) Size20mm
FlavorImprint Code PC17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51013-173-1520 in 1 BOTTLE; Type 0: Not a Combination Product06/23/2016
2NDC: 51013-173-2540 in 1 BOTTLE; Type 0: Not a Combination Product06/23/2016
3NDC: 51013-173-4324 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 finalpart34306/23/2016
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-173) , analysis(51013-173)

Revised: 8/2017
 
PuraCap Pharmaceutical LLC


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