LEADER DAY TIME
-
acetaminophen,
dextromethorphan hydrobromide and
phenylephrine hydrochloride capsule, liquid filled
Cardinal Health
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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Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
temporarily relieves common cold/flu symptoms:
- •
- nasal congestion
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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
- •
- fever
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
- •
- more than 4,000 mg of acetaminophen in 24 hours
- •
- with other drugs containing acetaminophen
- •
- 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, 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.
- •
- 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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- heart disease
- •
- thyroid disease
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- diabetes
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- high blood pressure
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- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
- •
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
- •
- you get nervous, dizzy or sleepless
- •
- pain, nasal congestion or cough 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 headache that lasts. These could be signs of a serious condition.
Directions
- •
- take only as directed – see Liver warning
- •
- do not exceed 4 doses 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 |
Inactive ingredients
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 INFORMATION
Non-Drowsy
Compare to Vicks® DayQuil® LiquiCaps® active ingredients
Day·Time
Cold & Flu
Multi-Symptom Relief
Nasal Decongestant - Cough Suppressant
Fever Reducer - Pain Reliever
Acetaminophen – aches, fever
Dextromethorphan HBr – cough
Phenylephrine HCl – nasal congestion
ALCOHOL FREE
ANTIHISTAMINE FREE
| LEADER DAY TIME
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part341 | 10/06/2006 | |
| Labeler - Cardinal Health (097537435) |
Revised: 08/2012 Cardinal Health