Delsym
FDA Label NDC 54868-6003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Delsym (NDC 54868-6003). 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 other, active ingredient (in each 5 ml), purpose, uses, otc - do not use, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: Reckitt Benckiser, Parsippany, NJ 07054-0224 ©RB 2011

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma        74146

Active Ingredient (In Each 5 Ml)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant

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

Otc - 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)

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - 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

  • 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
  • mL = milliliter
    • adults and children 12 years of age and over10 mL every 12 hours,
    not to exceed 20 mL in 24 hours
    children 6 to under 12 years of age5 mL every 12 hours,
    not to exceed 10 mL in 24 hours
    children 4 to under 6 years of age2.5 mL every 12 hours,
    not to exceed 5 mL in 24 hours
    children under 4 years of agedo not use

Other Information

  • each 5 mL contains: sodium 7 mg
  • store at 20°-25°C (68°-77°F)
  • dosing cup provided

Inactive Ingredients

citric acid, edetate disodium, ethylcellulose, FD&C Yellow No. 6, flavor, high fructose corn syrup, methylparaben, polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, vegetable oil, xanthan gum

Questions?

1-888-963-3382     You may also report side effects to this phone number.

Principal Display Panel - 89 Ml Bottle Carton

NDC 54868-6003-0

Delsym®

Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant)

COUGH

DAY
OR
NIGHT

12
HOUR
COUGH RELIEF

Orange
Flavored Liquid

89 mL (3 fl oz)

Alcohol-free

Principal Display Panel (89 mL Bottle Carton)

Principal Display Panel (89 mL Bottle Carton)

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