HEALTHY ACCENTS SINUS RELIEF- acetaminophen, guaifenesin, diphenhydramine hcl, phenylephrine hcl kit
Healthy Accents Sinus Relief by
Drug Labeling and Warnings
Healthy Accents Sinus Relief by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- Active ingredients (in each caplet) – SINUS RELIEF Day
- Active ingredients (in each caplet) – SINUS RELIEF Night
- Purpose – SINUS RELIEF Day
- Purpose – SINUS RELIEF Night
-
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
-
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,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients (SINUS RELIEF Day only)
- Inactive ingredients (SINUS RELIEF Night only)
- Questions or comments?
-
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
-
INGREDIENTS AND APPEARANCE
HEALTHY ACCENTS SINUS RELIEF
acetaminophen, guaifenesin, diphenhydramine hcl, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 55316-936 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 55316-936-80 1 in 1 KIT; Type 0: Not a Combination Product 02/06/2015 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 5 BLISTER PACK 10 Part 2 5 BLISTER PACK 10 Part 1 of 2 HEALTHY ACCENTS SINUS RELIEF
acetaminophen, guaifenesin, phenylephrine hcl capsule, coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 19mm Flavor Imprint Code L145 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 5 in 1 CARTON 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/06/2015 Part 2 of 2 HEALTHY ACCENTS SINUS RELIEF
acetaminophen, diphenhydramine hcl, phenylephrine hcl capsule, coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape CAPSULE Size 16mm Flavor Imprint Code L625 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 5 in 1 CARTON 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/06/2015 Labeler - DZA Brands LLC (090322194)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.