Amerisource Bergen Cough DM ER Drug Facts

Amerisource Bergen Cough DM ER Drug Facts

Drug Labeling and Warnings

Drug Details

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GOOD NEIGHBOR PHARMACY COUGH DM ER- dextromethorphan polistirex suspension 
Amerisource Bergen

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Amerisource Bergen Cough DM ER Drug Facts

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant

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

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.

Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

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

  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • 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.

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 (1-800-222-1222).

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 doctor
  • mL = milliliter

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 5 mg
  • store at 20° to 25°C (68° to 77°F)
  • dosing cup provided

Inactive Ingredients

D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Delsym® active ingredient

12 HOUR COUGH RELIEF

Cough

DM ER

dextromethorphan polistirex

extended-release oral suspension

Cough Suppressant

Orange-Flavored Liquid

Dosing Cup Included

Alcohol-Free – Day or Night

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions

5 fl oz (148 mL)

Good Neighbor Pharmacy Cough DM ER image
GOOD NEIGHBOR PHARMACY COUGH DM ER 
dextromethorphan polistirex suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 46122-141
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
POLISTIREX (UNII: 5H9W9GTW27)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ACETATE (UNII: 32K497ZK2U)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
SUCROSE (UNII: C151H8M554)  
TARTARIC ACID (UNII: W4888I119H)  
TRAGACANTH (UNII: 2944357O2O)  
TRIACETIN (UNII: XHX3C3X673)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 46122-141-211 in 1 CARTON08/30/2012
189 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 46122-141-251 in 1 CARTON08/02/2013
2148 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09113508/30/2012
Labeler - Amerisource Bergen (007914906)

Revised: 10/2016
 
Amerisource Bergen


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