Childrens daytime cold and cough liquid

Drug facts

Active ingredient (in each5 mL,1 teaspoonful)

Dextromethorphan HBr, USP 5 mg
Phenylephrine HCl, USP 2.5 mg

Purpose

Cough suppressant
Nasal decongestant

Uses

  • temporarily relieves
    • 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts, or as occurs with asthma

When using this product

  • do not exceed recommended dosage

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 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

  • 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 useany other dosing device.
  • mL= milliliter
  • tsp = teaspoon full
Age
Dose
children under 4 years of age
do not use
children 4 to under 6 years of age
5 mL (1 teaspoonful)
children 6 to under12 years of age
10 mL (2 teaspoonfuls)

Other information

  • each 5 mL oral dose (1 teaspoonful) contains:sodium 1.5 mg
  • store at controlled room temperature 20-25C (68-77F)
  • see bottom panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C Red # 40, flavors, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate, xanthan gum

Questions or comments?

1-855-274-4122


PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

5000 KANSAS AVE

KANSAS CITY, KS 66106

Ingredients and appearance - Product information

Childrens daytime cold and cough liquid- Dextromethorphan hbr, phenylephrine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 63941-973
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 5 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)
Cherry ( UNII: BUC5I9595W)
Clove ( UNII: K48IKT5321)
Edetate disodium ( UNII: 7FLD91C86K)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Maltitol ( UNII: D65DG142WK)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sodium citrate, unspecified form ( UNII: 1Q73Q2JULR)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Color RED Flavor CHERRY (Prosweet and Clove)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Best Choice( 868703513)

Establishment

Name ID/FEI Business Operations
Best Choice 868703513 ANALYSIS( 63941-973), MANUFACTURE( 63941-973)

Package label-principal display panel 4 fl oz (118 ml bottle)

Best Choice ®
NDC 63941-973-24

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S
TRIAMINIC ®SYRUP DAY TIME COLD & COUGH*

Children's
DAYTIME
COLD & COUGH SYRUP

Each 5 mL (1 tsp)dose of oral solution contains:

5 mg - Dextromethorphan HBr,USP(Cough Suppressant)
2.5 mg - Phenylephrine HCl, USP(Nasal Decongestant)

Relieves:

  • Stuffy Nose
  • Cough

Cherry Flavor

Alcohol Free
4 FL OZ (118 mL)