Expectorant Plus Cough Relief
FDA Label NDC 66007-204

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Capricorn Pharma Inc. for the product Expectorant Plus Cough Relief (NDC 66007-204). 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 ingredients (in each packet), purpose, uses, otc - do not use, ask a doctor before use if you have, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Packet)

Dextromethorphan HBr 5mg

Guaifenesin 100mg


Purpose

Cough Suppressant

Expectorant

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive■ temporarily relieves:■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants■ the intensity of coughing■ 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

■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
■ cough that occurs with too much phlegm (mucus)

Directions

■ empty entire contents of packet onto tongue and swallow with a glass of water
■ for best taste, do not chew granules
■ do not take more than 6 doses in any 24-hour period

Age
Dose
adults and children 12 years and over
2 to 4 packets every 4 hours
children 6 years to under 12 years
1 to 2 packets every 4 hours
children 4 years to under 6 years
1 packet every 4 hours
children under 4 years
do not use

Other Information

■ store between 20-25°C (68-77°F).
■ tamper evident: do not use if carton is open or if packets are torn or open.
■ see below for lot number and expiration date

Inactive Ingredients

Cocoa butter, confectioners sugar, crospovidone, lactose, maltodextrin, methacrylic acid copolymer, microcrystalline cellulose, modified cornstarch, flavor, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, sorbitan monostearate, starch, sucralose, sugar, talc, triethyl citrate

Principal Display Panel

Capricorn PharmaORIGINAL DEVELOPERS AND MANUFACTURERSCompare to the active ingredients of Mucinex Cough Mini-MeltsFOR KIDSFor ages 4-12Expectorant plus Cough ReliefDEXTROMETHORPHAN HBr 5mg - Cough SuppressantGUAIFENESIN 100mg - ExpectorantRelieves Chest CongestionThins and loosens mucusControls coughGreat taste, Easy to TakeFLASHBEADS12 PacketsOrange Flavor

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