Cough Relief Liquid
FDA Label NDC 36800-509

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Top Care (topco Associates Llc) for the product Cough Relief (NDC 36800-509). 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 (in each 5 ml), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, when using this product,, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each 5 Ml)

→ Purpose

→ Uses

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Stop Use And Ask A Doctor If

→ When Using This Product,

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

→ Package Label

Active Ingredient (In Each 5 Ml)

Dextromethorphan HBr 15 mg

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

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)

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.

When Using This Product,

do not use more than directed

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

take recommended dosage or as directed by a doctor
measure only with dosing cup provided. Do not use any other dosing device
keep dosing cup with product
shake well before using
mL=milliliter

age	dose
adults and children 12 years and over	10 mL every 6-8 hours not to exceed 4 doses in 24 hours,
children 6 to 11 years of age	5 mL every 6-8 hours not to exceed 4 doses in 24 hours
children under 6 years of age	do not use

Other Information

each 5 mL contains: sodium 3 mg
store at 20-25°C (68°-77°F). Do not refrigerate.

Inactive Ingredients

anhydrous citric acid, disodium EDTA, FD&C yellow #6, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sucralose, sucrose, xanthan gum