Warnings

Do not use 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 you have

chronic cough that lasts such as occurs with smoking, asthma, or emphysema
cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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

shake bottle well before use
measure only with dosing cup provided
do not use dosing cup with other products
dose as follows or as directed by a doctor

adults and children 12 years of age and over	10 mL every 12 hours, not to exceed 20 mL in 24 hours
children 6 to under 12 years of age	5 mL every 12 hours, not to exceed 10 mL in 24 hours
children 4 to under 6 years of age	2.5 mL every 12 hours, not to exceed 5 mL in 24 hours
children under 4 years of age	do not use

Other information

each 5 mL contains: sodium 7 mg
store at 20-25°C (68-77°F)
dosing cup provided

Inactive ingredients

citric acid, edetate disodium, ethylcellulose, FD&C yellow no. 6, flavor, high fructose corn syrup, methylparaben, partially hydrogenated vegetable oil (soybean, cottonseed), polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, xanthan gum

Questions?

You may also report side effects to this phone number.

Distributed by: RB Health (US), Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

NDC 63824-177-65
Ages 4+

Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant)

12
HOUR
COUGH RELIEF ™

Orange
Flavored Liquid

148 mL (5 fl oz)
For Children & Adults

PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63824-177
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN (UNII: 7355X3ROTS) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
POLISTIREX (UNII: 5H9W9GTW27)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)
TRAGACANTH (UNII: 2944357O2O)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	Score
Shape	Size
Flavor	ORANGE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63824-177-63	1 in 1 CARTON	08/19/2011
1	89 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
2	NDC:63824-177-65	1 in 1 CARTON	07/01/2017	10/03/2024
2	148 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA018658	08/19/2011

Labeler - RB Health (US) LLC (081049410)