Maximum Strength-cough And Chest Congestion Dm Capsule, Liquid Filled
FDA Label NDC 53345-034

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd. for the product Maximum Strength-cough And Chest Congestion Dm (NDC 53345-034). 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 softgel), purpose, uses, do not use if, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Softgel)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 mg

Purpose

Cough suppressant

Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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.       

Stop Use And Ask A Doctor If

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Directions

• do not take more than 12 softgels in any 24-hour period
• this adult product is not intended for use in children under 12 years of age

age

dose

adults and children 12 years and over

2 softgels every 4 hours

children under 12 years

do not use

Other Information

• store at room temperature 15-30°C (59-86°F)
• avoid excessive heat above 40°C (104°F)

Inactive Ingredients

FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Wuhan, Hubei
430206, China

Principal Display Panel - Shipping Label

Maximum Strength-Cough and Chest Congestion DM Liquid Filled Capsules
Quantity : 4000 Capsules
NDC. No : 53345-034-01

IMPORTANT:

  • Inspect immediately upon receipt.
  • This is a bulk shipment, intended for further processing only.
  • Protect from heat, humidity, and light. Do not refrigerate.
  • Store at 15-30°C (59-86°F)


    • CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

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