TOPCARE DAYTIME NITETIME MULTI SYMPTOM RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
Topco Associates 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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Topco Associates LLC. DayTime NiteTime Drug Facts
Active ingredients for Nighttime (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Active ingredient for Daytime (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
temporarily relieves common cold/flu symptoms:
- •
- cough due to minor throat and bronchial irritation
- •
- sore throat
- •
- headache
- •
- minor aches and pains
- •
- fever
- •
- relieves runny nose and sneezing (Nighttime only)
- •
- nasal congestion (Daytime only)
Warnings
Liver warning: These products contain acetaminophen. The maximum daily dose of these products is 8 softgels (2,600 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 these products
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
- •
- 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.
- •
- to make a child sleepy (Nighttime only)
- •
- 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 (Daytime only)
- •
- thyroid disease (Daytime only)
- •
- diabetes (Daytime only)
- •
- high blood pressure (Daytime only)
- •
- cough that occurs with too much phlegm (mucus)
- •
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- •
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- •
- trouble urinating due to an enlarged prostate gland
- •
- glaucoma (Nighttime only)
Ask a doctor or pharmacist before use if you are
- •
- taking sedatives or tranquilizers (Nighttime only)
- •
- 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
- •
- may cause marked drowsiness
- •
- 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 directed - see Liver warning
- •
- take Nighttime OR Daytime
Nighttime Softgels
- •
- do not exceed 8 softgels per 24 hrs
|
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 |
Daytime Softgels
- •
- do not exceed 8 softgels per 24 hrs
|
adults & children 12 yrs & over |
2 softgels with water every 4 hrs |
|
children 4 to under 12 yrs |
ask a doctor |
|
children under 4 yrs |
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, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution
Daytime edible ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution
Principal Display Panel
SEE NEW WARNINGS & DIRECTIONS
COLD & FLU – NON-DROWSY
MULTI-SYMPTOM RELIEF
DayTime
Pain Reliever/Fever Reducer – Acetaminophen
Cough Suppressant – Dextromethorphan HBr
Nasal Decongestant – Phenylephrine HCl
Alcohol Free / Antihistamine Free
COMPARE TO VICKS® DAYQUIL® active ingredients
actual size
SEE NEW WARNINGS & DIRECTIONS
COLD & FLU
MULTI-SYMPTOM RELIEF
NiteTime
Pain Reliever/Fever Reducer – Acetaminophen
Cough Suppressant – Dextromethorphan HBr
Antihistamine – Doxylamine Succinate
Alcohol Free
COMPARE TO VICKS® NYQUIL® active ingredients
actual size
SPECIAL VALUE!
COMBINATION PACK
| TOPCARE DAYTIME NITETIME
MULTI SYMPTOM RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit |
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| Labeler - Topco Associates LLC (006935977) |