DAY TIME PE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled 
Mckesson (Sunmark)

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

Dextromethoprhan Hydrobromide 10 mg

Phenlyephrine 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 threat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 more alcoholic drinks everyday 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, see a doctor promptly.

Do not use

  • with any other drug containing acetaminophen (prescription or non prescription). 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

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
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • symptoms do not get better within 7 days
  • cough lasts more than 7 days (adults) or 5 days (children), comes back or occurs with fever rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health care professional before use.

Keep out of reach of children.

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed- see overdose warning
  • do not exceed 4 doses per 24 hours

 adults and children 12 years and over
 swallow 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 day time or night time products, carefully read each label to insure correct dosing

Other information

  • store at room temperature 15o- 30o C (59o- 86o F) and avoid excessive heat
  • **This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil®

Inactive Ingredients

butylated hydroxyanisole, butylated hydroxytoluene, edible white printing ink, FD&C Red #40*, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, and sorbitol

*May contain this ingredient

Questions or comments?

Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Product Labeling

Compare to Vicks® Dayquil® active ingredients**

day time liquid PE

Relieves major cold and flu symptoms

Non- drowsy

pain reliever, fever reducer, cough suppressant, nasal congestant

aches, fever, sore throat.....acetaminophen

cough...................................dextromethorphan hydrobromide
nasal congestion..................phenylephrine HCl

multi-symptom

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

Another quality product distributed by McKesson
One Post Street
San Francisco, CA 94104
Money Back Guarantee
www.sunmarkbrand.com

sunmark brand

daytime PE cold and flu relief


DAY TIME PE  COLD AND FLU RELIEF
acetaminohpen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-738
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
BUTYLATED HYDROXYANISOLE 
BUTYLATED HYDROXYTOLUENE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorORANGE (red) Scoreno score
ShapeCAPSULE (Oblong) Size19mm
FlavorImprint Code P19;36A;95A
Contains    
Packaging
#Item CodePackage Description
1NDC:49348-738-021 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:49348-738-472 in 1 CARTON
210 in 1 BLISTER PACK
3NDC:49348-738-042 in 1 CARTON
312 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/09/2010
Labeler - Mckesson (Sunmark) (177667227)

Revised: 09/2012
 
Mckesson (Sunmark)