Pain Relief by Healthy Accents (DZA Brands, LLC) Drug Facts

Pain Relief by

Drug Labeling and Warnings

Pain Relief by is a Otc medication manufactured, distributed, or labeled by Healthy Accents (DZA Brands, LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • headache
  • the common cold
  • backache 
  • minor arthritis pain 
  • 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 8 tablets in 24 hours, which is the maximum daily amount
• 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.

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 tablets every 4 to 6 hours while symptoms last
  • do not take more than 8 tablets 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 at controlled room temperature 15°-30°C (59°-86°F)

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain this ingredient

Questions or comments?

Call toll free 1-866-322-2439

Principal Display Panel

**Compare to Extra Strength Tylenol®  active ingredient

Extra Strength

Pain Relief

Acetaminophen, 500 mg

pain reliever fever reducer

contain no aspirin

Tablets

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

**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®.

DISTRIBUTED BY: DZA BRANDS, LLC

Salisbury, NC 28147

Scarborough, ME 04074

Product Label

Healthy Accents Extra Strength Pain Relief Tablets

PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	TCL252
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-016-10	10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/30/2013	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	12/30/2013	12/31/2019

Labeler - Healthy Accents (DZA Brands, LLC) (090322194)

Revised: 11/2019

Document Id: 0bc8addd-6ee6-4b25-9c97-d888dcca665b

34390-5

Set id: 143cdaaa-9abf-43ee-8a8f-ae261b7f8e71

Version: 2

Effective Time: 20191105

 

Healthy Accents (DZA Brands, LLC)