GOOD SENSE DAYTIME NON DROWSY COLD AND FLU
-
acetaminophen,
dextromethorphan hydrobromide and
phenylephrine hydrochloride liquid
L Perrigo Company
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 ingredient (in each 15 mL tablespoon)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult/child takes more than 4 doses in 24 hours, which is the maximum daily amount for this product
- taken with other drugs containing acetaminophen
- adult has 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
- 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
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- 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 5 days (children) or 7 days (adults)
- 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
- use dose cup
- do not exceed 4 doses per 24 hrs
| adults & children 12 yrs & over | 30 ml (2 TBSP) every 4 hrs |
| children 6 to under 12 yrs | 15 ml (1 TBSP) every 4 hrs |
| children 4 to under 6 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
butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum
Principal Display Panel
Multi-Symptom Relief
Non-Drowsy
See New Warnings and Dosing Information
DayTime
Cold&Flu
Acetaminophen – Aches, Fever
Dextromethorphan HBr – Cough
Phenylephrine HCl – Nasal Congestion
Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant
Compare to active ingredients of Vicks® DayQuil®
Alcohol Free
Antihistamine Free
DayTime Label Image 1
DayTime Label Image 2
| GOOD SENSE DAYTIME
NON DROWSY COLD AND FLU
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part341 | 07/25/2006 | |
| Labeler - L Perrigo Company (006013346) |
Revised: 09/2011 L Perrigo Company