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

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Cough and Cold

Accudial Pharmaceutical, Inc.

Children's ACCUDIAL


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

COUGH & COLD LONG-ACTING

Drug Facts

Active ingredient

Purpose

Active ingredients
(in each 5 mL tsp)
Purposes
Chlorpheniramine maleate, USP 1 mg Antihistamine
Dextromethorphan HBr, USP 7.5 mg Cough suppressant

Cough and Cold Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat

Warnings

Do not use

  • to sedate a child or to make a child sleepy
  • if you are now 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if the child has

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product

  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than 4 doses in any 24-hour period
  • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
  • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
age dose
under 6 years do not use
6 to under 12 years 1-2 tsp. (5-10 mL) every 6 hours

Cough and Cold Other information

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

Inactive ingredients

artificial flavor, citric acid, FD&C red #40, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose.

Questions?

877-434-2036

PRINCIPAL DISPLAY PANEL - 118 mL Carton

CHILDREN'S
ACCUDIAL

ROTATING DOSING LABEL

Cough & Cold
Long-Acting

ACCURATE DOSING
BY WEIGHT

Chlorpheniramine Maleate
(Antihistamine)

Dextromethorphan HBr
(Cough Suppressant)

RELIEVES
Cough: Up to 8 Hours
Runny Nose

For Ages 6 to under 12

Compares to Children's
Robitussin® Cough &
Cold Long-Acting.

FRUIT
PUNCH
FLAVOR

4 FL. OZ.
(118 mL)
NDC 45014-151-04

Cough and Cold

Cough and Cold

Chlorpheniramine Maleate and Dextromethorphan Hydrobromide LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:45014-151
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Chlorpheniramine Maleate CHLORPHENIRAMINE 1 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 7.5 mg

Inactive Ingredients

Ingredient Name Strength
fruit
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
water
SODIUM BENZOATE
SODIUM CITRATE
sorbitol
Sucralose

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45014-151-04 118 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-11-25


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Be sure to consult your doctor before taking any medication!
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