Kroger Co. Children’s Nite Time Cold & Cough Drug Facts

Kroger Co. Children’s Nite Time Cold & Cough Drug Facts

Drug Labeling and Warnings

Drug Details

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NITE TIME COLD AND COUGH CHILDRENS- diphenhydramine hcl, phenylephrine hcl solution 
Kroger Company

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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Kroger Co. Children’s Nite Time Cold & Cough 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
  • itchy nose or throat
  • runny nose
  • 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. 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
  • to make a 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 sedatives or tranquilizers

When using this product

  • do not exceed recommended dosage
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • symptoms do improve within 7 days or occur with fever
  • cough persists for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

Keep out of reach of children.

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

Directions

  • may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor.
  • use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device.

Age

Dose

children under

4 years of age

do not use

children 4 to under

6 years of age

do not use unless

directed by a doctor

children 6 to under

12 years of age

10 mL

Other information

  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F)

Inactive ingredients

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

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredients of CHILDREN’S TRIAMINIC® NIGHT TIME COLD & COUGH

See back panel

Children’s

Nite Time Cold & Cough

Triacting Syrup

Diphenhydramine HCl, Antihistamine/Cough Suppressant

Phenylephrine HCl, Nasal Decongestant

Relieves:

Cough

Runny, Stuffy Nose

Itchy Throat

Grape Flavor

4 FL OZ (118 mL)

Kroger Children's Nite Time Cold & Cough image
NITE TIME COLD AND COUGH  CHILDRENS
diphenhydramine hcl, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 30142-021
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 30142-021-261 in 1 CARTON
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/29/2007
Labeler - Kroger Company (006999528)

Revised: 4/2016
 
Kroger Company


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