Day Time Cold and Flu description, usages, side effects, indications, overdosage, supplying and lots more!

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Day Time Cold and Flu

Preferred Plus (Kinray)
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

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Day Time Cold and Flu Uses

  • temporarily relieves common cold and flu symptoms:
    • minor aches and 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. 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 Day-Time or Nite-Time products, carefully read each label to insure correct dosing

Day Time Cold and Flu Other information

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

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

†Compare to the Active Ingredients in Vicks® DayQuil® LiquiCaps®

Day-Time

Cold & Flu

Multi-Symptom Relief

  • Minor Aches & Pains
  • Headache
  • Sore Throat
  • Fever
  • Cough
  • Nasal Congestion

NON-DROWSY Softgels

ACETAMINOPHEN, Dextromethorphan Hydrobromide, Phenylephrine HCl

Alcohol Free

Antihistamine Free

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

Distributed by: Kinray Inc.

152-35 Tenth Avenue

Whitestone, NY  11357

©2013 Kinray Inc. All Rights Reserved, PREFERRED PLUS, PREFERRED PLUS++++ and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray Inc. All other marks are property of their respective owners.

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

Product Label

Day Time Cold and Flu
Preferred Plus Day-Time Cold & Flu Softgel

Day Time Cold and Flu

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61715-042
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
GLYCERIN
POLYETHYLENE GLYCOLS
POVIDONES
propylene glycol
water
SORBITAN
sorbitol

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 12 in 1 BLISTER PACK
2 NDC:61715-042-24 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-03-31


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Be sure to consult your doctor before taking any medication!
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