RUNNY NOSE & COUGH

Drug Facts

Active ingredients (in each 5 mL tsp)	Purposes
Brompheniramine maleate, USP .5 mg	Antihistamine
Dextromethorphan HBr, USP 5 mg	Cough suppressant
Phenylephrine HCl, USP 1.25 mg	Nasal decongestant

Uses

temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
temporarily restores freer breathing through the nose

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

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
glaucoma
cough that occurs with too much phlegm (mucus)
a breathing problem or persistent or chronic cough that lasts such 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
may cause marked drowsiness
avoid alcoholic beverages
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

you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days or are accompanied by fever
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
children 6 to under 12 years	1½-3 tsp. (7.5-15 mL) every 6 hours
children under 6 years	do not use

Other information

each teaspoon contains: sodium 3 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol.

Questions?

877-434-2036

PRINCIPAL DISPLAY PANEL - 118 mL Carton

CHILDREN'S
ACCUDIAL

ROTATING DOSING LABEL

ACCURATE DOSING
BY WEIGHT

Nasal Decongestant
Antihistamine
Cough Suppressant

RELIEVES
Nasal Congestion
Runny Nose
Itchy, Watery Eyes
Coughing, Sneezing

For Ages 6 to under 12

Alcohol Free
Compares to the
active ingredients in
Children's Dimetapp®
Cold & Cough.

GRAPE
FLAVOR

4 FL. OZ.
(118 mL)
NDC 45014-153-04

Runny Nose & Cough

RUNNY NOSE AND COUGH
brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45014-153
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Brompheniramine Maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN)	Brompheniramine Maleate	0.5 mg in 5 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	5 mg in 5 mL
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	1.25 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
Grape (UNII: 6X543N684K)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C Red No. 40 (UNII: WZB9127XOA)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)
Sodium Benzoate (UNII: OJ245FE5EU)
Sodium Citrate (UNII: 1Q73Q2JULR)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sorbitol (UNII: 506T60A25R)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:45014-153-04	118 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	11/04/2009

Labeler - Accudial Pharmaceutical, Inc. (831999201)

Children's ACCUDIAL