COUGH & COLD LONG-ACTING

Drug Facts

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Accudial Pharmaceutical, Inc. (831999201)

Children's ACCUDIAL