PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet 
Healthy Accents (DZA Brands, 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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Drug Facts

Active ingredient

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

Uses

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

Warnings

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. 

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

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

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. 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 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: do not use 

Other information

  • store between 20-25ºC (68-77ºF)

Inactive ingredients

corn starch, croscarmellose sodium*, hypromellose*, lactose monohydrate*, magnesium stearate*, mineral oil*, polyethylene glycol*, polyvinyl alcohol*, povidone, purified water*, sodium starch glycolate, stearic acid*, talc*, titanium dioxide

*contains one or more of these ingredients 

Questions or comments?

Call toll free 1-866-322-2439 

Principal Display Panel

 Extra Strength

Pain Relief

Acetaminophen, 500 mg

Pain reliever

Fever reducer

contains no aspirin

Caplets

**Compare to the active ingredient in Tylenol® Extra Strength

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Extra Strength. 

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: DZA BRANDS, LLC

SALISBURY, NC 28147

SCARBOROUGH, ME 04074

For product questions or concerns,

contact us at 1-866-322-2439

Product Label

Acetaminophen 500 mg

Healthy Accents Extra Strength Pain Relief Caplets

PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-457
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE (UNII: FZ989GH94E)  
WATER (UNII: 059QF0KO0R)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code TCL341;P500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-457-1010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/28/201512/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/28/201512/31/2020
Labeler - Healthy Accents (DZA Brands, LLC) (090322194)

Revised: 11/2019
Document Id: 0eba1b14-6589-43c1-8116-a0a581fa8f20
Set id: 78a50306-aa3e-4ea6-a18b-c4e6e4317ee0
Version: 2
Effective Time: 20191105
 
Healthy Accents (DZA Brands, LLC)