CVS Pharmacy, Inc. Children’s Cold & Cough Drug Facts

Childrens Cough and Cold by

Drug Labeling and Warnings

Childrens Cough and Cold by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CHILDRENS COUGH AND COLD NIGHTTIME- diphenhydramine hcl, phenylephrine hcl solution 
CVS Pharmacy

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.

----------

CVS Pharmacy, Inc. Children’s Cold & Cough Drug Facts

Active ingredients (in each 5 mL)

Diphenhydramine HCl, USP 6.25 mg

Phenylephrine HCl, USP 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 occurs
  • symptoms do not get better 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 20-25ºC (68-77ºF)

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?

1-800-719-9260

Principal Display Panel

Compare to the active ingredients in Triaminic® Night Time Cold & Cough

Nighttime

Children’s Cold & Cough

DIPHENHYDRAMINE HCl

Antihistamine; Cough suppressant

PHENYLEPHRINE HCl

Nasal decongestant

Relieves:

Cough

Runny, stuffy nose

Itchy throat

Grape Flavor

Ages 6 Years & Over

Dosage cup included

4 FL OZ (118 mL)

CVS Health Children's Cold & Cough image
CHILDRENS COUGH AND COLD  NIGHTTIME
diphenhydramine hcl, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59779-539
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: 59779-539-261 in 1 CARTON07/22/201511/30/2019
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 finalpart34107/22/201511/30/2019
Labeler - CVS Pharmacy (062312574)

Revised: 11/2019
Document Id: 4f24858a-bcc7-4d68-a2b6-324e5d783b2a
Set id: c830a0ba-c786-49cb-9b03-162262fff9e4
Version: 3
Effective Time: 20191125
 
CVS Pharmacy