COUGH AND COLD- chlorpheniramine maleate and dextromethorphan hydrobromide liquid

Cough and Cold by

Drug Labeling and Warnings

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

COUGH & COLD LONG-ACTING

Drug Facts

ACTIVE INGREDIENT

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

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

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

INGREDIENTS AND APPEARANCE

COUGH AND COLD 
chlorpheniramine maleate and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45014-151
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U)	Chlorpheniramine Maleate	1 mg  in 5 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	7.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Fruit (UNII: C2AIY4ERZC)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Sodium Benzoate (UNII: OJ245FE5EU)
Sodium Citrate (UNII: 1Q73Q2JULR)
Sorbitol (UNII: 506T60A25R)
Sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	RED (Reddish-Pink) , PINK	Score
Shape		Size
Flavor	FRUIT PUNCH	Imprint Code
Contains

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	11/25/2009

Labeler - Accudial Pharmaceutical, Inc. (831999201)