CHILDRENS DAYTIME COLD AND COUGH- dextromethorphan hbr, phenylephrine hydrochloride liquid

Childrens Daytime Cold and Cough by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredient (in each 5 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 use any 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 under 12 years of age: 10 mL (2 teaspoonfuls)

Other information

• each 5 mL oral dose (1 teaspoon ful) contains: sodium 1.5 mg
• store at controlled room temperature 20-25°C (68-77°F)
• 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

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike,
Lawrenceville, NJ 08648

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (118 mL Bottle)

AUROHEALTH
NDC: 58602-145-24

Compare to the active ingredient in Children's
Triaminic® Syrup Day Time Cold & Cough*

Children's
AUROMINIC
Syrup

Day Time
Cold & Cough

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

Alcohol-Free       Cherry Flavor

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS DAYTIME COLD AND COUGH 
dextromethorphan hbr, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-145
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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	Score
Shape		Size
Flavor	CHERRY (Prosweet and Clove)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58602-145-24	1 in 1 CARTON	08/13/2015
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	08/13/2015

Labeler - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(58602-145)