Tukol Maxium Strength Cough And Mucus Relief
FDA Label NDC 50066-601

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa, Inc for the product Tukol Maxium Strength Cough And Mucus Relief (NDC 50066-601). 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 drug facts active ingredients, purpose, keep out of reach of children, uses, warnings do not use, ask a doctor before use if you have, stop use and ask a doctor if, 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

Drug Facts Active Ingredients

Dextromethorphan HBr 10 mg
Guaifenesin 200 mg

Purpose

Cough Suppressant
Expectorant

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.

Uses

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

Warnings 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

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop Use And Ask A Doctor If

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

If Pregnant Or Breast-Feeding

ask a health professional before use.

Directions

  • Do not take more than 12 softgels in any 24-hour period
  • This product is not intended for use in children under 12 years
  • Adults and children 12 years and over - 2 softgels every 4 hours
  • Children under 12 years of age - do not use

Other Information

  • Store at room temperature
  • Avoid excessive heat above 40° C (104° F)

Inactive Ingredients

FD and C Red # 40, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide

Questions Or Comments?

1-877-99 GENOM (43666)

Tukol Maximum Strength Cough And Mucus Relief Label

Tukol®

Dextromethorphan HBr-Cough suppressant / Guaifensin-Expectorant

Relieves

Cough
Mucus

Use in the morning, evening or anytime

MAIMUM STRENGTH

For ages 12 and over

20 SOFTGELS

Do not use if plastic blister is open or broken

Made in India
Distributed by Genomma Lab USA, Inc. Houston, TX 77027

BX - 048


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