DAYTIME COUGH AND COLD- dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

Daytime Cough And Cold by

Drug Labeling and Warnings

Daytime Cough And Cold by is a Otc medication manufactured, distributed, or labeled by Accudial Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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.

QUESTIONS

877-434-2036

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

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	1.25 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Accudial Pharmaceutical, Inc. (831999201)