DAYTIME COUGH AND COLD- dextromethorphan hydrobromide and phenylephrine hydrochloride solution

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., Bio-Pharm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each 5 mL = 1 teaspoon)	Purpose
Dextromethorphan HBr, USP 5 mg	Cough suppressant
Phenylephrine HCl, USP 2.5 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.

Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.

Age (yr)	Dose (TSP)
under 4 yrs.	ask a doctor
4 to under 6	1 TSP
6 to under 12	2 TSP
or as directed by a doctor
TSP = teaspoon

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

Other information

• each teaspoon contains: sodium 2 mg
• store between 20°-25°C (68°-77°F)
• tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.

Directions

• may be given every 4 hours
• do not use more than 6 times in 24 hours
• use only enclosed dosing cup to dose this product. Do not use any other dosing device.

Questions?

877-434-2036

Inactive ingredients

artificial flavor, benzoic acid, citric acid, EDTA disodium dihydrate, FD&C red #40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

SPL UNCLASSIFIED SECTION

Distributed by: AccuDial® Pharmaceutical, Inc.
Palm Beach Gardens, FL 33408

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

ACCUDIAL®

Children's
Daytime
Cough and Cold

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves Cough Stuffy Nose

Earth-Friendly
Package!

For Ages 4 yrs to under 12 yrs

Tamper Evident

Compares to Children's Triaminic ®
Day Time Cold & Cough

CHERRY
FLAVOR

NDC: 45014-158-04
4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

DAYTIME COUGH AND COLD 
dextromethorphan hydrobromide and phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45014-158
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
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	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45014-158-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	02/01/2013

Labeler - Accudial Pharmaceutical, Inc. (831999201)

Establishment
Name	Address	ID/FEI	Business Operations
Bio-Pharm, Inc.		801652546	ANALYSIS(45014-158) , MANUFACTURE(45014-158) , RELABEL(45014-158) , REPACK(45014-158)