DailyMed - GOOD NEIGHBOR PHARMACY COUGH DM ER- dextromethorphan polistirex suspension

NDC Code(s): 46122-141-21, 46122-141-25
Packager: Amerisource Bergen

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 1, 2020

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Active ingredient (in each 5 mL)
Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide
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Purpose
Cough suppressant

Cough suppressant
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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

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

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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 ...

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.

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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).

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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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 - adults and children 12 years ...

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

•

each 5 mL contains: sodium 5 mg

•

store at 20° to 25°C (68° to 77°F)

•

dosing cup provided

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Inactive Ingredients
D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, glycerin, high fructose corn syrup, methylparaben, natural and artificial orange flavor, polysorbate 80, polyvinyl acetate, povidone ...

D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, glycerin, high fructose corn syrup, methylparaben, natural and artificial orange flavor, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum
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Questions or comments?
1-800-719-9260

1-800-719-9260
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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 ...

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

3 fl oz (89 mL)

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INGREDIENTS AND APPEARANCE

Product Information

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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

Published Date (What is this?)	Version	Files
Jul 6, 2020	5 (current)	download
Nov 27, 2019	4	download
Dec 6, 2016	3	download
Oct 18, 2013	2	download
Nov 8, 2012	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1373045	dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension	PSN
2	1373045	12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension	SCD
3	1373045	dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension	SY
4	1373045	dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension	SY

Label: GOOD NEIGHBOR PHARMACY COUGH DM ER- dextromethorphan polistirex suspension

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	46122-141-21
2	46122-141-25

Label: GOOD NEIGHBOR PHARMACY COUGH DM ER- dextromethorphan polistirex suspension

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

Find additional resources

Safety

Related Resources

More Info on this Drug

GOOD NEIGHBOR PHARMACY COUGH DM ER- dextromethorphan polistirex suspension

Number of versions: 5

GOOD NEIGHBOR PHARMACY COUGH DM ER- dextromethorphan polistirex suspension

GOOD NEIGHBOR PHARMACY COUGH DM ER- dextromethorphan polistirex suspension

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GOOD NEIGHBOR PHARMACY COUGH DM ER- dextromethorphan polistirex suspension

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.