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Night Time Cold and Cough Childrens

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 6.25mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Best Choice (Valu Merchandisers Company)
NDC Code: 63941-079

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.

Drug Facts

Active ingredients (in each 5 mL)

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg

Purposes

Antihistamine/Cough suppressant

Nasal decongestant

Uses

temporarily relieves:

  • sneezing
  • runny nose
  • itchy nose or throat
  • itchy, watery eyes due to hay fever
  • nasal and sinus congestion
  • cough due to minor throat and bronchial irritation as may occur with a cold

Warnings

Do not use
  • in a child under 4 years of age
  • in a child who is 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 contains an MAOI, ask a doctor or pharmacist before giving this product.
  • with any other product containing diphenhydramine, even one used on skin
  • for the purpose of making your child sleepy

Ask a doctor before use if the chld has
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts, or as occurs with asthma
  • a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers

When using this product
  • do not exceed recommended dosage
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.

These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions
  • Do not give more than 6 doses in 24 hours unless directed by a doctor. 
  • mL = milliliter
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
AgeDose 
children 6 to under 12 years 10 mL every 4 hours 
children 4 to under 6 years do not use unless directed by a doctor 
children under 4 years of age do not use 

Other information
  • each 5 mL contains: sodium 3 mg
  • store between 20-25º (68-77ºF). Do not refrigerate.
  • protect from light

Inactive ingredients

acesulfame potassium, citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, maltitol, propylene glycol, purifed water, sodium benzoate, sodium citrate

Questions or comments?

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

Principal Display Panel

FOR AGES 6 to 11 YEARS

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S TRIAMINIC® NIGHTTIME COLD & COUGH SYRUP 

Children's

Night Time

Cold and Cough Syrup

Diphenhydramine HCl

  • Antihistamine/ Cough suppressant

Phenylephrine HCl

  • Nasal decongestant

GRAPE FLAVOR

Dosing Cup Included

FL OZ (mL)

*This product is not manufactured or distributed by Novartis distributors of Children's Triaminic® Night Time Cold & Cough.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

5000 KANSAS AVE

KANSAS CITY, KS 66106

www.bestchoicebrand.com

Package Label

Best Choice Children's NightTime Cold & Cough Syrup Grape Liquid

NIGHT TIME COLD AND COUGH  CHILDRENS
diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-079
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
TRISODIUM CITRATE DIHYDRATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63941-079-041 BOTTLE, PLASTIC in 1 BOX
1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/31/2014
Labeler - Best Choice (Valu Merchandisers Company) (868703513)

 
Best Choice (Valu Merchandisers Company)

Medically reviewed on Jul 30, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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