DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE- dextromethorphan polistirex suspension 
Amneal Pharmaceuticals LLC

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Dextromethorphan Polistirex Extended-release Suspension
12 Hour Cough Relief
Orange

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

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

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

  
 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

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

30 mg/5 mL 3oz Label

30 mg/5 mL 3oz Carton
DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE 
dextromethorphan polistirex suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65162-700
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65162-700-761 in 1 CARTON08/01/2017
189 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:65162-700-771 in 1 CARTON08/01/2017
2148 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20313308/01/2017
Labeler - Amneal Pharmaceuticals LLC (123797875)
Establishment
NameAddressID/FEIBusiness Operations
Amneal Pharmaceuticals, LLC963900878ANALYSIS(65162-700) , LABEL(65162-700) , MANUFACTURE(65162-700) , PACK(65162-700)

Revised: 12/2020
Document Id: 20542a3d-7028-49a5-973f-4d49645dc526
Set id: ce7402d1-e48f-4bf1-90e9-cc57a52b35e5
Version: 8
Effective Time: 20201228
 
Amneal Pharmaceuticals LLC