DAYTIME COLD FLU NON-DROWSY- acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled 
SMART SENSE (Kmart)

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 325mg

Dextromethoprhan Hydrobromide 10mg

Phenlyephrine HCl 5mg

Purposes

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & 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 every day while using this product
Sore throat warning: If sore throat is sever, 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 other drugs 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 enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough that 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
  • symptoms get worse or last 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the 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 more than 4 doses in 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 DayTime or NightTime products, carefully read each label to insure correct dosing

Other information

  • store at room temperature 15º-30ºC (59º-86ºF) and avoid excessive heat

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 1-800-842-7886 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to active ingredients of Vicks® DayQuil®**

Non-Drowsy

COLD & FLU DayTime

Acetaminophen

Dextromethorphan Hydrobromide
Phenylephrine HCl

Pain reliever/Fever reducer
Cough Suppressant/Nasal Decongestant

SOFTGELS

**This product is not manufacured or distributed by Proctor & Gamble, owner of the registered trademark Vicks® DayQuil®

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMAITON

Product Labeling

 Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenylephrine HCl 5 mg

Smart sense Cold & Flu DayTime Non-Drowsy

DAYTIME COLD FLU NON-DROWSY 
acetaminohpen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-470
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 
POVIDONES 
PROPYLENE GLYCOL 
SORBITAN 
SORBITOL 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code P19;95A;36A
Contains    
Packaging
#Item CodePackage Description
1NDC:49738-470-241 in 1 BOX
124 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/31/2012
Labeler - SMART SENSE (Kmart) (008965873)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
 
SMART SENSE (Kmart)