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Healthy Accents Sinus Relief by DZA Brands LLC

Medically reviewed on December 7, 2017

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, GUAIFENESIN 200mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: DZA Brands LLC
NDC Code: 55316-936

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 Daytime Nighttime Sinus Relief Drug Facts

Active ingredients (in each caplet) – SINUS RELIEF Day

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active ingredients (in each caplet) – SINUS RELIEF Night

Acetaminophen 325 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 5 mg

Purpose – SINUS RELIEF Day

Pain reliever

Expectorant

Nasal decongestant

Purpose – SINUS RELIEF Night

Pain reliever

Antihistamine

Nasal decongestant

Uses
temporarily relieves:
nasal congestion
headache
minor aches and pains
sinus congestion and pressure
runny nose and sneezing (SINUS RELIEF Night only)
temporarily promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (SINUS RELIEF Day only)

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.
with any other product containing diphenhydramine, even one used on skin (SINUS RELIEF Night only)
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
diabetes
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
glaucoma (SINUS RELIEF Night only)
a breathing problem such as emphysema or chronic bronchitis (SINUS RELIEF Night only)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (SINUS RELIEF Day only)
cough that occurs with too much phlegm (mucus) (SINUS RELIEF Day only)

Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
taking sedatives or tranquilizers (SINUS RELIEF Night only)

When using these products
do not use more than directed
excitability may occur, especially in children (SINUS RELIEF Night only)
marked drowsiness may occur (SINUS RELIEF Night only)
alcohol, sedatives, and tranquilizers may increase drowsiness (SINUS RELIEF Night only)
avoid alcoholic drinks (SINUS RELIEF Night only)
be careful when driving a motor vehicle or operating machinery (SINUS RELIEF Night only)

Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occur
pain, cough 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
cough comes back or occurs with rash or persistent headache. These could be signs of a serious condition. (SINUS RELIEF Day only)

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 more than 10 caplets in any 24-hour period
adults and children 12 years and older: take 2 caplets every 4 hours
children under 12 years of age: do not use

Other information
each caplet contains: sodium 4 mg (SINUS RELIEF Day only)
store at 20-25°C (68-77°F)

Inactive ingredients (SINUS RELIEF Day only)

croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Inactive ingredients (SINUS RELIEF Night only)

crospovidone, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-866-322-2439

Package/Label Principal Display Panel - Daytime

maximum strength

sinus relief

day time

acetaminophen – pain reliever

guaifenesin – expectorant

phenylephrine HCl – nasal decongestant

relieves sinus pressure, headache & congestion

thins & loosens mucus

for ages 12+ - gluten free

SEE NEW WARNINGS

Compare to Mucinex® Sinus-Max® Day active ingredients

10 caplets

actual size

maximum strength

sinus relief

night time

acetaminophen – pain reliever

diphenhydramine HCl – antihistamine

phenylephrine HCl – nasal decongestant

relieves nasal congestion, sinus pressure & pain

relieves runny nose & sneezing

for ages 12+ - gluten free

SEE NEW WARNINGS

Compare to Mucinex® Sinus-Max® Night active ingredients

10 caplets

actual size

HEALTHY ACCENTS SINUS RELIEF 
acetaminophen, guaifenesin, diphenhydramine hcl, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-936
Packaging
#Item CodePackage Description
1NDC:55316-936-801 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 15 BLISTER PACK 10 
Part 25 BLISTER PACK 10 
Part 1 of 2
HEALTHY ACCENTS SINUS RELIEF 
acetaminophen, guaifenesin, phenylephrine hcl capsule, coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONES 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeL145
Contains    
Packaging
#Item CodePackage Description
15 BLISTER PACK in 1 CARTON
12 CAPSULE, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/06/2015
Part 2 of 2
HEALTHY ACCENTS SINUS RELIEF 
acetaminophen, diphenhydramine hcl, phenylephrine hcl capsule, coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONES 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeL625
Contains    
Packaging
#Item CodePackage Description
15 BLISTER PACK in 1 CARTON
12 CAPSULE, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart341
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/06/2015
Labeler - DZA Brands LLC (090322194)

 
DZA Brands LLC

← See all Healthy Accents Sinus Relief brands

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.

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