HEALTHY ACCENTS PAIN RELIEF- acetaminophen tablet, coated 
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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DZA Brands, LLC Pain Relief Drug Facts

Active ingredient (in each gelcap)

Acetaminophen 500 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 6 gelcaps (3,000 mg) in 24 hours. 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

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 have ever had an allergic reaction to this product or any of its ingredients

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.

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 Liver warning)

adults and children 12

years and over
•
take 2 gelcaps every 6 hours while symptoms last
•
do not take more than 6 gelcaps 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 20°-25°C (68°-77°F)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-866-322-2439

Principal Display Panel

Compare to Tylenol® Extra Strength Rapid Release Gels active ingredient

extra strength

rapid release

pain relief

acetaminophen - rapid release gelcaps

pain reliever - fever reducer - contains no aspirin

SEE NEW WARNINGS AND DIRECTIONS

500mg each

Pain Relief Carton Image 1

Pain Relief Carton Image 1

Pain Relief Carton Image 2

Pain Relief Carton Image 1

Pain Relief Carton Image 2

HEALTHY ACCENTS PAIN RELIEF 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-046
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorRED (grey top) Scoreno score
ShapeCAPSULE (tablet) Size19mm
FlavorImprint Code L046
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-046-711 in 1 CARTON04/01/201003/10/2014
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55316-046-781 in 1 CARTON04/01/201003/10/2014
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/01/201003/10/2014
Labeler - DZA Brands LLC (090322194)

Revised: 11/2017
Document Id: 3519a1eb-3c01-49ac-ab1c-747b66070d08
Set id: 7b092b48-ba57-4789-bb30-bf498c8a2896
Version: 3
Effective Time: 20171121
 
DZA Brands LLC