Childrens cough and coldnighttime solution

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 Parkinsons disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your childs 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 20-25C (68-77F)

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

Ingredients and appearance - Product information

Childrens cough and coldnighttime solution- Diphenhydramine hcl, phenylephrine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 59779-539
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 6.25 mgin 5 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 2.5 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
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

Color PURPLE Flavor GRAPE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - CVS Pharmacy( 062312574)

Principal display panel

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

Nighttime

Childrens 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)