daytime pe

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Publix Super Markets Inc
NDC Code: 56062-994

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.

Publix Super Markets, Inc. Daytime PE Drug Facts

Active ingredient (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

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. 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
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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information
store at 20°-25°C (68°-77°F)

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 and Directions

NON-DROWSY

daytime PE

ACETAMINOPHEN – ACHES, FEVER

DEXTROMETHORPHAN HBr – COUGH

PHENYLEPHRINE HCl – NASAL CONGESTION

PAIN RELIVER, FEVER REDUCER

COUGH SUPPRESSANT

NASAL DECONGESTANT

DOES NOT CONTAIN PSEUDOEPHEDRINE

Relieves major cold & flu symptoms

MULTI-SYMPTOM COLD/FLU RELIEF

16 SOFTGELS

ACTUAL SIZE

Compare to Active Ingredients in Vicks® DayQuil®

DAYTIME PE 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-994
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeL994
Contains    
Packaging
#Item CodePackage Description
1NDC:56062-994-531 BLISTER PACK in 1 CARTON
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:56062-994-602 BLISTER PACK in 1 CARTON
210 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
3NDC:56062-994-732 BLISTER PACK in 1 CARTON
38 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
4NDC:56062-994-622 BLISTER PACK in 1 CARTON
412 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/02/2006
Labeler - Publix Super Markets Inc (006922009)

Revised: 10/2013
 
Publix Super Markets Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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