DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE- dextromethorphan polistirex suspension

Dextromethorphan Polistirex Extended-Release by

Drug Labeling and Warnings

Dextromethorphan Polistirex Extended-Release by is a Otc medication manufactured, distributed, or labeled by Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

OTC - PURPOSE

Purpose

Cough suppressant

INDICATIONS AND USAGE

Uses

Temporarily relieves

• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
• the impulse to cough to help you get to sleep

WARNINGS

Warnings

OTC - DO NOT USE

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.

OTC - ASK DOCTOR

Ask a doctor before use if you have

• chronic cough that lasts 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, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

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° to 25°C (68° to 77°F)
• dosing cup provided
• mL = milliliter

INACTIVE INGREDIENT

Inactive ingredients

citric acid, corn oil, edetate disodium, ethylcellulose, FD&C Yellow No. 6, flavor, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sodium polystyrene sulfonate, sucrose, tragacanth, xanthan gum

Hydrochloric acid or sodium hydroxide solution, if required, to adjust the pH.

OTC - QUESTIONS

Questions?

Call 1-877-835-5472, Mon through Fri 9AM to 5PM EST.

Distributed by:
Amneal Pharmaceuticals
Bridgewater, NJ 08807

Rev. 06-2016-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE 
dextromethorphan polistirex suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65162-700
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN OIL (UNII: 8470G57WFM)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
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)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65162-700-76	1 in 1 CARTON	08/01/2017
1		89 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 65162-700-77	1 in 1 CARTON	08/01/2017
2		148 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203133	08/01/2017

Labeler - Amneal Pharmaceuticals LLC (123797875)

Establishment
Name	Address	ID/FEI	Business Operations
Amneal Pharmaceuticals, LLC		963900878	ANALYSIS(65162-700) , LABEL(65162-700) , MANUFACTURE(65162-700) , PACK(65162-700)