Delsym
FDA Label NDC 21695-518

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Delsym (NDC 21695-518). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, directions, inactive ingredients, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Dextromethorphan Polistirex

Purpose

Use(s)

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

Uses

Use(s)

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

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.

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)

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

Stop use and ask a doctor if 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

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.

Directions

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 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

• each 5 mL contains: sodium 7 mg

• store at 20°-25°C (68°-77°F)

• dosing cup provided

Drug Facts

Distributed by: Reckitt Benckiser Inc., Parsippany, NJ 07054-0224 ©RBI 2009

Inactive Ingredients

Inactive ingredients

citric acid anhydrous, D&C Red #33, edetate disodium, ethylcellulose, FD&C Blue #1, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben,

purified water, sucrose, tragacanth, vegetable oil, xanthan gum

Package/Label Principal Display Panel

Delsym 30mg/ 5ml (4abb0813 E080 4bae B829 E2c29d0a8d4f 01)

Delsym 30mg/ 5ml (4abb0813 E080 4bae B829 E2c29d0a8d4f 01)

Delsym 30mg/ 5ml (4abb0813 E080 4bae B829 E2c29d0a8d4f 02)

Delsym 30mg/ 5ml (4abb0813 E080 4bae B829 E2c29d0a8d4f 02)

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