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
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
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
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adults and children 12 years and over |
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children under 12 years |
ask a doctor |
NIGHTTIME
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adults and children 12 years and over |
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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
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 AND PAIN
DAYTIME NIGHTTIME
acetaminophen,phenylephrine hcl, chlorpheniramine maleate kit |
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| Labeler - DZA Brands LLC (090322194) |
| Registrant - L. Perrigo Company (006013346) |