Daytime Cough and Cold description, usages, side effects, indications, overdosage, supplying and lots more!

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Daytime Cough and Cold

Accudial Pharmaceutical, Inc.

Daytime Cough & Cold


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

Daytime Cough and Cold 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.

Daytime Cough and Cold 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.

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

ACCU DIAL ®

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)

Daytime Cough and Cold

Daytime Cough and Cold

Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:45014-158
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C RED NO. 40
propylene glycol
water
SODIUM CITRATE
saccharin sodium
sorbitol

Product Characteristics

Color
RED

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-02-01


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Be sure to consult your doctor before taking any medication!
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