DAYTIME PE- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled
Publix Super Markets Inc
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 softgel)
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 you take
- more than 12 softgels in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
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 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 recommended – see Liver warning
- 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
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
NON-DROWSY
daytime PE
ACETAMINOPHEN - ACHES, FEVER
DEXTROMETHORPHAN HBr - COUGH
PHENYLEPHRINE HCl - NASAL CONGESTION
PAIN RELIEVER, FEVER REDUCER
COUGH SUPPRESSANT
NASAL DECONGESTANT
DOES NOT CONTAIN PSEUDOEPHEDRINE
MULTI-SYMPTOM COLD/FLU RELIEF
Relieves major cold & flu symptoms
ACTUAL SIZE
Compare to Active Ingredients in Vicks® DayQuil®
Daytime PE Carton Image 1
Daytime PE Carton Image 2
| DAYTIME PE
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled |
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| Labeler - Publix Super Markets Inc (006922009) |