Cough DM description, usages, side effects, indications, overdosage, supplying and lots more!

Cough DM

Safeway

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Safeway Inc. Cough DM Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

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?

1-888-SAFEWAY

Package/Label Principal Display Panel

Compare to Delsym® active ingredient

12 Hour Cough Relief

For Children & Adults

Cough DM

Dextromethorphan Polistirex Extended-Release Oral Suspension

Cough Suppressant

Contains Sodium Metabisulfite, a Sulfite That May Cause Allergic-Type Reactions

Alcohol-Free

Dosing Cup Included

Orange-Flavored Liquid For Children & Adults

3 FL OZ (89 mL)

Cough DM

dextromethorphan polistirex SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21130-958
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 30 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
METHYLPARABEN
polysorbate 80
POVIDONES
PROPYLPARABEN
water
SODIUM METABISULFITE
Sodium Polystyrene Sulfonate
SUCROSE
tartaric acid
TRAGACANTH
triacetin
XANTHAN GUM

Product Characteristics

Color
ORANGE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 89 in 1 BOTTLE
2 NDC:21130-958-21 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091135 2013-06-25


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.