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Childrens Cold and Cough Nighttime

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 6.25mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Safeway, Inc.
NDC Code: 21130-379

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 HCI 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 irritations 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. If you do not know if your child's prescription 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 child 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 sedative 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 occurs
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with 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.
  • measure only with dosing cup provided Do not use any other dosing device
  • keep dosing cup with product
  • mL=mililiter
AgeDose 
 children 6 to under 12 years 10 mL every 4 hours
 children 4 to under 6 yearsdo not use unless directed by a doctor
 children under 4 years do not use 

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

Inactive ingredients

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

Questions or comments?

 Call 1-888-723-3929  Monday-Friday 7AM-6PM PST

Principal Display Panel

Compare to Children's Triaminic® NightTime Cold & Cough active ingredients*

Childrens's Nighttime Cold & Cough Relief

FOR AGES 6-11 YEARS

Diphenhydramine HCl 6.25 mg - Antihistamine/Cough Suppressant

Phenylephrine HCl 2.5 mg - Nasal Decongestant

GRAPE FLAVOR

  • Relief of: Cough, itchy throat, runny & stuffy nose
  • Dosing cup included

FL OZ (mL)

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

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

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

Package Label

SIGNATURE CARE Children's Nighttime Cold & Cough Relief

CHILDRENS COLD AND COUGH  NIGHTTIME
diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-379
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 
SODIUM BENZOATE 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
FD&C RED NO. 40 
TRISODIUM CITRATE DIHYDRATE 
FD&C BLUE NO. 1 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-379-041 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 FINALpart34112/31/2015
Labeler - Safeway, Inc. (009137209)

 
Safeway, Inc.

← See all Childrens Cold and Cough Nighttime brands

Medically reviewed on Jun 15, 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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