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.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

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)

Daytime Cough And Cold 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.

Daytime Cough And Cold 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

Daytime Cough And Cold

Daytime Cough And Cold

Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:45014-152
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 1.25 mg

Inactive Ingredients

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

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-10-26


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Be sure to consult your doctor before taking any medication!
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