DZA Brands, LLC Sinus Congestion & Pain DayTime NightTime Drug Facts

healthy accents sinus congestion and pain by

Drug Labeling and Warnings

healthy accents sinus congestion and pain by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC, L. Perrigo Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHY ACCENTS SINUS CONGESTION AND PAIN DAYTIME NIGHTTIME- acetaminophen,phenylephrine hcl, chlorpheniramine maleate 
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 Sinus Congestion & Pain DayTime NightTime Drug Facts

Active ingredients (in each caplet) Sinus Congestion & Pain Day

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Active ingredients (in each caplet) Sinus Congestion & Pain Night

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purpose (Day)

Pain reliever

Nasal decongestant

Purpose (Night)

Pain reliever

Antihistamine

Nasal decongestant

Uses (Day)

  • for the temporary relief of:
  • headache
  • sinus congestion and pressure
  • nasal congestion
  • minor aches and pains
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages
  • temporarily reduces fever

Uses (Night)

  • for the temporary relief of:
  • headache
  • sinus congestion and pressure
  • nasal congestion
  • runny nose and sneezing
  • minor aches and pains
  • reduces swelling of nasal passages
  • helps decongest sinus openings and passages
  • temporarily reduces fever

Warnings

Liver warning: These products contain 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 these products

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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking these products.
  • if you have ever had an allergic reaction to these products or any of their ingredients

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using these products

  • do not exceed recommended dosage

In addition, when using Sinus Congestion & Pain Night:

  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

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)
  • do not take the Day and Night caplets at the same time
  • do not take more than a total of 10 caplets in 24 hours

DAYTIME

adults and children 12 years and over

  • take 2 caplets every 4 hours
  • swallow whole – do not crush, chew or dissolve

children under 12 years

ask a doctor

NIGHTTIME

adults and children 12 years and over

  • take 2 caplets every 4-6 hours
  • swallow whole – do not crush, chew or dissolve

children under 12 years

ask a doctor

Inactive ingredients

DAYTIME acesulfame potassium, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

NIGHTTIME acesulfame potassium, carnauba wax, flavor, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-866-322-2439

Principal Display Panel

SEE NEW WARNINGS

Compare to Tylenol® Sinus Congestion & Pain active ingredients

sinus congestion & pain

pain reliever/fever reducer - nasal decongestant – antihistamine*

daytime – non-drowsy

contains 2 medicines for adults:

sinus headache (acetaminophen)

sinus pressure / nasal congestion (phenylephrine HCl)

gluten free

actual size

12 Cool Ice® caplets

instant cooling sensation

nighttime

contains 3 medicines for adults:

sinus headache (acetaminophen)

sinus pressure / nasal congestion (phenylephrine HCl)

runny nose (chlorpheniramine maleate)

*antihistamine in nighttime only

gluten free

actual size

8 Cool Ice® caplets

instant cooling sensation

Healthy Accents Sinus Congestion & Pain image 1
Healthy Accents Sinus Congestion & Pain image 2
Healthy Accents Sinus Congestion & Pain image 3
HEALTHY ACCENTS SINUS CONGESTION AND PAIN  DAYTIME NIGHTTIME
acetaminophen,phenylephrine hcl, chlorpheniramine maleate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55316-886
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55316-886-561 in 1 CARTON; Type 0: Not a Combination Product10/10/201102/01/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 BLISTER PACK 12 
Part 24 BLISTER PACK
Part 1 of 2
HEALTHY ACCENTS SINUS CONGESTION AND PAIN  DAYTIME
acetaminophen, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code L272
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 CARTON
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/10/201102/01/2018
Part 2 of 2
HEALTHY ACCENTS SINUS CONGESTION AND PAIN  NIGHTTIME
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorWHITE (off white) Score2 pieces
ShapeCAPSULESize16mm
FlavorImprint Code L476
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 CARTON
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/10/201102/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/10/201102/01/2018
Labeler - DZA Brands LLC (090322194)
Registrant - L. Perrigo Company (006013346)

Revised: 12/2019
 
DZA Brands LLC