Drug Facts

Active ingredients (in each 5 mL, 1 teaspoonful)	Purposes
Dextromethorphan HBr, USP 5 mg	Cough suppressant
Phenylephrine HCl, USP 1.25 mg	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 right away.

Directions

May be given every 6 hours. Do not give more than 4 doses in 24 hours unless directed by a doctor.

Children under 4 years of age	do not use
Children 4 to under 6 years of age	1-1½ tsp. (5-7.5 mL)
Children 6 to under 12 years of age	1½-3 tsp. (7.5-15 mL)

Other information

each teaspoon contains: sodium 2 mg
store at controlled room temperature 20°-25°C (68°-77°F)

Inactive ingredients

Artificial Flavor, Benzoic Acid, Citric Acid, EDTA Disodium, FD&C Red #40, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

question image 877-434-2036

Manufactured for
ACCUDIAL
PHARMACEUTICAL, INC.
AccurateDose.com
Palm Beach Gardens, FL 33410

Distributed by:
LeSaint Logistics
Corporate Headquarters
2570 Northwest Parkway
Elgin, IL 60124

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

CHILDREN'S
ACCUDIAL

ROTATING DOSING LABEL

Daytime
Cough & Cold

ACCURATE DOSING
BY WEIGHT

Dextromethorphan HBr
(Cough Suppressant)

Phenylephrine HCl
(Nasal Decongestant)

Cough
Stuffy Nose

For Ages 4 to under 12

Compares to the active
ingredients in Children's
Triaminic® Day Time
Cold & Cough.

CHERRY
FLAVOR

4 FL.OZ.
(118 mL)

NDC 45014-152-04

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

DAYTIME COUGH AND COLD
dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45014-152
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	5 mg in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	1.25 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
Cherry (UNII: BUC5I9595W)
Benzoic acid (UNII: 8SKN0B0MIM)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Edetate Disodium (UNII: 7FLD91C86K)
FD&C red no. 40 (UNII: WZB9127XOA)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sodium Citrate (UNII: 1Q73Q2JULR)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:45014-152-04	118 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	10/26/2009

Labeler - Accudial Pharmaceutical, Inc. (831999201)