TopCare Cough DM

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

• 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

OTC - STOP USE SECTION

• 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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 a doctor

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial grape flavor, D&C Red #30 aluminum lake, FD&C Blue #1 aluminum lake, 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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare_® health

COMPARE TO DELSYM^® ACTIVE INGREDIENT

Cough DM

DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE ORAL SUSPENSION

COUGH SUPPRESSANT

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

12 HOUR RELIEF

GRAPE FLAVORED LIQUID

5 FL OZ (148 mL)

ALCOHOL-FREE

Day or Night

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DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

• TopCare Cough DM
• dextromethorphan polistirex
• DEXTROMETHORPHAN HYDROBROMIDE
• DEXTROMETHORPHAN
• D&C RED NO. 30 ALUMINUM LAKE
• FD&C BLUE NO. 1 ALUMINUM LAKE
• GLYCERIN
• HIGH FRUCTOSE CORN SYRUP
• METHYLPARABEN
• POLYSORBATE 80
• POLYVINYL ACETATE
• POVIDONE, UNSPECIFIED
• PROPYLPARABEN
• WATER
• SODIUM METABISULFITE
• SODIUM POLYSTYRENE SULFONATE
• SUCROSE
• TARTARIC ACID
• TRAGACANTH
• TRIACETIN
• XANTHAN GUM

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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Source XML

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Observed Orange Book product history#

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