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healthy accents sinus congestion and pain day time

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: DZA Brands LLC
NDC Code: 55316-272

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 Congestion & Pain Drug Facts

Active ingredients (in each caplet)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Nasal decongestant

Uses
temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) 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 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.
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
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 exceed recommended dosage

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.

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 caplets every 4 hours
swallow whole – do not crush, chew or dissolve
do not take more than 10 caplets in 24 hours

children under 12 years

ask a doctor

Other information
store at 20-25°C (68-77°F)
do not use if blister unit is broken or torn

Inactive ingredients

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

Questions or comments?

1-866-322-2439

Principal Display Panel

Compare to Tylenol® Sinus Congestion & Pain Daytime active ingredients

daytime – non-drowsy

sinus congestion & pain

pain reliever/fever reducer

nasal decongestant

for adults – gluten free

contains 2 medicines:

headache (acetaminophen)

sinus pressure/nasal congestion (phenylephrine HCl)

actual size

24 Cool Ice® caplets

instant cooling sensation

HEALTHY ACCENTS SINUS CONGESTION AND PAIN  DAY TIME
acetaminophen, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-272
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 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
POVIDONES 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
CROSPOVIDONE 
Product Characteristics
ColorGREENScoreno score
ShapeOVAL (caplet, film-coated) Size16mm
FlavorImprint CodeL272
Contains    
Packaging
#Item CodePackage Description
1NDC:55316-272-6212 BLISTER PACK in 1 CARTON
12 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/10/2008
Labeler - DZA Brands LLC (090322194)

Revised: 12/2013
 
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.

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