HEALTHY ACCENTS DAY TIME NIGHT TIME- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
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 Day Time Night Time Drug Facts
Active ingredients for NIGHTTIME (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Active ingredients for DAYTIME (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
temporarily relieves common cold/flu symptoms:
- •
- nasal congestion (DAYTIME ONLY)
- •
- cough due to minor throat and bronchial irritation
- •
- sore throat
- •
- headache
- •
- minor aches and pains
- •
- fever
- •
- relieves runny nose and sneezing (NIGHTTIME ONLY)
Warnings
Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take
- •
- more than 8 softgels in 24 hours (Nighttime) or more than 12 softgels in 24 hours (Daytime), which is the maximum daily amount
- •
- with other drugs containing acetaminophen
- •
- 3 or more alcoholic drinks every day while using these products
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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.
- •
- to make a child sleepy
Ask a doctor before use if you have
- •
- heart disease (DAYTIME ONLY)
- •
- thyroid disease (DAYTIME ONLY)
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- diabetes (DAYTIME ONLY)
- •
- high blood pressure (DAYTIME ONLY)
- •
- cough that occurs with too much phlegm (mucus)
- •
- liver disease
- •
- persistent or chronic cough as occurs with smoking, asthma or emphysema
- •
- trouble urinating due to an enlarged prostate gland
- •
- glaucoma (NIGHTTIME ONLY)
- •
- a breathing problem such as emphysema or chronic bronchitis (NIGHTTIME ONLY)
Ask a doctor or pharmacist before use if you are
- •
- taking sedatives or tranquilizers
- •
- taking the blood thinning drug warfarin
When using these products
- •
- do not use more than directed
In addition, when using NIGHTTIME:
- •
- excitability may occur, especially in children
- •
- marked drowsiness may occur
- •
- avoid alcoholic drinks
- •
- be careful when driving a motor vehicle or operating machinery
- •
- alcohol, sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- •
- you get nervous, dizzy or sleepless (DAYTIME ONLY)
- •
- redness or swelling is present
- •
- fever gets worse or lasts more than 3 days
- •
- new symptoms occur
- •
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- •
- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Directions
- •
- take only as recommended - see Liver warning
- •
- take Nighttime OR Daytime
NIGHTTIME SOFTGELS
- •
- do not exceed 4 doses per 24 hours
|
adults and children 12 years and over |
2 softgels with water every 6 hours |
|
children 4 to under 12 years |
ask a doctor |
|
children under 4 years |
do not use |
DAYTIME SOFTGELS
- •
- do not exceed 6 doses per 24 hours
|
adults and children 12 years and over |
2 softgels with water every 4 hours |
|
children 4 to under 12 years |
ask a doctor |
|
children under 4 years |
do not use |
- •
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Inactive ingredients
NIGHTTIME D&C yellow no. 10, edible ink, FD&C blue no. 1, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
DAYTIME edible ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Principal Display Panel
SEE NEW WARNINGS INFORMATION
Day Time
Multi-Symptom
Cold/Flu Relief
Relieves Major Cold/Flu-Like Symptoms So You Can Cope
Pain Reliever / Fever Reducer
Cough Suppressant / Nasal Decongestant
Aches, Fever - Acetaminophen
Cough - Dextromethorphan HBr
Nasal Congestion - Phenylephrine HCl
Non-Drowsy
Compare to active ingredients of Vicks® DayQuil®
Antihistamine Free
Alcohol Free
SEE NEW WARNINGS INFORMATION
Night Time
Multi-Symptom
Cold/Flu Relief
Relieves Cold & Flu-Like Symptoms So You Can Rest
Fever Reducer / Pain Reliever
Antihistamine / Cough Suppressant
Aches, Fever - Acetaminophen
Cough - Dextromethorphan HBr
Sneezing, Runny Nose - Doxylamine Succinate
Compare to active ingredients of Vicks® NyQuil®
Alcohol Free
Day Time Night Time Carton Image 2
| HEALTHY ACCENTS DAY TIME NIGHT TIME
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit |
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| Labeler - DZA Brands LLC (090322194) |