DayTime Cold Flu Non-Drowsy description, usages, side effects, indications, overdosage, supplying and lots more!

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DayTime Cold Flu Non-Drowsy

SMART SENSE (Kmart)
P and L Development of New York Corporation

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethoprhan HBr 10 mg

Phenlyephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

DayTime Cold Flu Non-Drowsy Uses

  • temporarily relieves common cold and flu symptoms:
    • minor aches & pains
    • headache
    • sore throat
    • nasal congestion
    • fever
    • cough due to minor throat and bronchial irritation

Warnings

Liver warning: This product contains acetaminophen. 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, 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
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product,

do not exceed recommended dosage.

Stop use and ask a doctor if

  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • nervousness, dizziness, or sleeplessness occur 
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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 recommended dose can cause liver damage. 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

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 4 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use
  • when using other DayTime or NightTime products, carefully read each label to insure correct dosing

DayTime Cold Flu Non-Drowsy Other information

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

Inactive ingredients

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

*may contain this ingredient

Questions or comments?

 Call toll free 1-800-842-7886

Principal Display Panel

Compare to the active ingredients of Vicks® DayQuil® LiquiCaps®†

Non-Drowsy  Alcohol-Free   Antihistamine-Free

COLD & FLU DayTime

Acetaminophen

Dextromethorphan Hydrobromide

Phenylephrine HCl

Pain Reliever/Fever Reducer

Cough Suppressant/Nasal Decongestant

SOFTGELS

†This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark Vicks® DayQuil® LiquiCaps®.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: Kmart Corporation

Hoffman Estates, IL  60179

Shop kmart.com

Product Labeling

DayTime Cold Flu Non-Drowsy

Smart Sense DayTime Cold & Flu Softgel
 

DayTime Cold Flu Non-Drowsy

ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49738-470
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
ORANGE 19 mm P19;95A;36A CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:49738-470-24 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-12-31


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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