Pill Identifier App

healthy accents sinus

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: DZA Brands LLC
NDC Code: 55316-886

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.

DZA Brands, LLC Sinus Drug Facts

Active ingredient (in each caplet) - Nighttime

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purpose - Nighttime

Pain reliever

Antihistamine

Nasal decongestant

Uses - Nighttime
  • 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

Warnings - Nighttime

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

  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • 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 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 this product.
  • to make a child sleepy

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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product
  • do not use more than directed
  • 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
  • you get nervous, dizzy or sleepless
  • 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.

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 - Nighttime
  • do not take more than directed (see Liver warning)
  • do not take the Day and Night caplets at the same time
  • do not take more than a total of 12 caplets in 24 hours
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
  • do not use this adult product in children under 12 years of age

Inactive ingredients - Nighttime

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

Questions or comments? - Nighttime

1-866-322-2439

Active ingredient (in each caplet) - Daytime

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose - Daytime

Pain reliever

Nasal decongestant

Uses - Daytime
  • 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

Warnings - Daytime

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

  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • 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 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 this product.

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • 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.

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 - Daytime
  • do not take more than directed (see Liver warning)
  • do not take the Day and Night caplets at the same time
  • do not take more than a total of 12 caplets in 24 hours
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

do not use this adult product in children

under 12 years of age

Inactive ingredients - Daytime

acesulfame potassium, carnauba wax, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, starch, stearic acid, talc, titanium dioxide

Questions or comments? - Daytime

1-866-322-2439

Principal Display Panel

See New Warnings Information

Sinus

Congestion & Pain

Pain Reliever / Nasal Decongestant / Antihistamine*

Day Time

Contains 2 Medicines:

Headache – Acetaminophen

Sinus Pressure, Nasal Congestion – Phenylephrine HCl

Non-Drowsy

Night Time

Contains 3 Medicines:

Headache – Acetaminophen

Sinus Pressure, Nasal Congestion – Phenylephrine HCl

Runny Nose – Chlorpheniramine Maleate

*Antihistamine in Nighttime only

COOL ICE®

Instant Cooling Sensation

Compare to active ingredients of Tylenol® Sinus Congestion & Pain Day & Night

Sinus Carton Image 1

Sinus Carton Image 2

HEALTHY ACCENTS SINUS 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-886
Packaging
#Item CodePackage Description
1NDC:55316-886-041 KIT (KIT) in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 12 
Part 21 BLISTER PACK 12 
Part 1 of 2
NIGHT TIME 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CARNAUBA WAX 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITE (off white) Score2 pieces
ShapeOVALSize16mm
FlavorVANILLAImprint CodeL476
Contains    
Packaging
#Item CodePackage Description
11 BLISTER PACK (BLISTER PACK) in 1 KIT
112 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/10/2008
Part 2 of 2
DAY TIME 
acetaminophen, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
CARNAUBA WAX 
CROSPOVIDONE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize16mm
FlavorImprint CodeL272
Contains    
Packaging
#Item CodePackage Description
11 BLISTER PACK (BLISTER PACK) in 1 KIT
112 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/10/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/10/2008
Labeler - DZA Brands LLC (090322194)

Revised: 02/2012
 
DZA Brands LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)