HEALTHY ACCENTS NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled
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 Nighttime Drug Facts
Active ingredient (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Uses
temporarily relieves common cold/flu symptoms:
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- cough due to minor throat and bronchial irritation
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- sore throat
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- headache
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- minor aches and pains
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- fever
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- runny nose and sneezing
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 8 softgels (2,600 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
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- to make a child sleepy
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- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
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- liver disease
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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem such as emphysema or chronic bronchitis
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- persistent or chronic cough as occurs with smoking, asthma, or emphysema
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- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
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- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
When using this product
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- excitability may occur, especially in children
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- may cause marked drowsiness
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- avoid alcoholic drinks
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- be careful when driving a motor vehicle or operating machinery
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- alcohol, sedatives, and tranquilizers may increase drowsiness
Directions
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- take only as directed – see Liver warning
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- do not exceed 8 softgels per 24 hours
|
adults & children 12 yrs & over |
2 softgels with water every 6 hrs |
|
children 4 to under 12 yrs |
ask a doctor |
|
children under 4 yrs |
do not use |
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- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Inactive ingredients
D&C yellow no. 10, edible ink, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution
Principal Display Panel
Compare to Vicks® NyQuil® Cold & Flu active ingredients
nighttime
cold & flu
pain reliever
fever reducer
cough suppressant
antihistamine
aches, fever, sore throat (acetaminophen)
cough (dextromethorphan HBr)
sneezing, runny nose (doxylamine succinate)
SEE NEW WARNINGS AND DIRECTIONS
alcohol free
| HEALTHY ACCENTS NIGHTTIME
COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled |
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| Labeler - DZA Brands LLC (090322194) |