CareOne Cough DM DEXTROMETHORPHAN POLISTIREX AMERICAN SALES COMPANY FDA Approved 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
FunFoxMeds box
Route
ORAL
Applications
ANDA091135
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide
Inactive Ingredients
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
Strengths
5 ml 30 mg
Quantities
89 ml
Treats Conditions
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
Pill Appearance
Color: orange

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
9D2RTI9KYH
Packaging

Package/Label Principal Display Panel Compare to the active ingredient in Children’s Delsym® For Ages 4+ Children’s COUGH DM Dextromethorphan Polistirex Extended-Release Oral Suspension Cough Suppressant For Children & Adults Day or Night Alcohol-Free 12hr Cough Relief dosing cup included Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions OUR PHARMACISTS RECOMMEND Orange-Flavored Liquid 3 FL OZ (89mL) children's cough DM image

Package Descriptions
  • Package/Label Principal Display Panel Compare to the active ingredient in Children’s Delsym® For Ages 4+ Children’s COUGH DM Dextromethorphan Polistirex Extended-Release Oral Suspension Cough Suppressant For Children & Adults Day or Night Alcohol-Free 12hr Cough Relief dosing cup included Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions OUR PHARMACISTS RECOMMEND Orange-Flavored Liquid 3 FL OZ (89mL) children's cough DM image

Overview

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

Indications & 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

Dosage & 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 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

Warnings & Precautions
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.
Purpose

Purpose Cough suppressant

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

Stop Use & Ask a Doctor

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.

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 1-800-222-1222.

Storage & Handling

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

Questions

Questions or comments? 1-800-719-9260


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