Perrigo Dextromethorphan Polistirex Extended-Release Oral Suspension Drug Facts

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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

SPL UNCLASSIFIED 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, 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?

OTC - QUESTIONS SECTION

1-800-719-9260

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50436-0433

NDC: 50436-0433-1 89 mL in a BOTTLE

DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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• dextromethorphan polistirex extended release
• dextromethorphan polistirex
• DEXTROMETHORPHAN HYDROBROMIDE
• DEXTROMETHORPHAN
• POLISTIREX
• D&C RED NO. 30
• D&C YELLOW NO. 10
• 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

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