Honey Tulsi Cough Drops
FDA Label NDC 57631-129

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Invatech Pharma Solutions Llc for the product Honey Tulsi Cough Drops (NDC 57631-129). 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, purposes, uses, warnings, ask a doctor before use if you have, 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

Active Ingredient

Menthol (From Mentha spicata) (in each 3gm Drop of Serving Size)....................................................3.9 mg

Purposes

Soothing sore throats

Uses

  • Natural way of calming cough and soothing sore throats

Warnings

Sore throat warnings: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.
Do not use for children under 6 years of age unless directed by a doctor.

Ask A Doctor Before Use If You Have

  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Stop Use And Ask A Doctor If

  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persist or worsens

Directions

  • adults and children 6 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as if needed or as directed by a doctor
  • children under 6 years: ask a doctor
  • do not bite or chew

Other Information

Protect from heat and moisture

Inactive Ingredients

Basil oil, honey, eucalyptus, camphor, thymol, fast green color q.s., flavored sugar base q.s.

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Honey Tulsi Cough Drops
100ct Bag

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