Cardinal Health Children’s Cough DM Drug Facts

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 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

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

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER_™

Children’s Cough DM

Dextromethorphan Polistirex

Extended-Release Oral Suspension

Cough Suppressant

Day or Night

For Children & Adults

Orange Flavored Liquid

COMPARE TO CHILDREN’S DELSYM^® ACTIVE INGREDIENT

Age 4+

12 Hour Relief

Dosing Cup Included

Alcohol-Free

Contains No Fever Reducer or Pain Reliever

100% Money Back Guarantee

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

3 FL OZ (89 mL)

DailyMed Product Concepts#

DailyMed Billing Units#

Products#

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

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

• leader childrens cough dm
• dextromethorphan polistirex
• DEXTROMETHORPHAN HYDROBROMIDE
• DEXTROMETHORPHAN
• D&C RED NO. 30 ALUMINUM LAKE
• D&C YELLOW NO. 10 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#

Every source-derived ingredient row is available through these pages.

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

Source Document#

Source XML

Older Hydrated Versions#

Orange Book application contexts#

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Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.