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

Runny Nose and Cough by

Drug Labeling and Warnings

Runny Nose and Cough 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

RUNNY NOSE & COUGH

Drug Facts

ACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Accudial Pharmaceutical, Inc. (831999201)