natural herb cough drops

natural herb cough drops
SPL v2
SPL
SPL Set ID fce6b5fa-846d-9911-e053-6294a90afc9b
Route
oral
Published
Effective Date 2023-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (1.1 mg)
Inactive Ingredients
peppermint horehound melissa officinalis flower thyme tilia cordata flower sage malva sylvestris leaf citric acid monohydrate ascorbic acid aspartame sambucus nigra flower hyssopus officinalis flowering top wild thyme isomalt beta carotene

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: oval Color: yellow Size: 25 mm
Marketing Status
otc monograph drug active Since 2023-05-29
Description

Active Ingredient: Menthol 1.1 mg.............oral anesthetic

Medication Information

Warnings and Precautions

Warnings

Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. If sore mouth symptons does not improve in 7 days see your dentist or doctor promptly. These symptoms maybe serious.

Active Ingredient

Active Ingredient:

  • Menthol 1.1 mg.............oral anesthetic
Indications and Usage

Uses temporarily relieves:

ocassional minor irritation and pain associated with:

  • sore mouth
  • sore throat

Dosage and Administration

Directions

  • Adults and children 6 years and over: dissolve 2 drop slowly in mouth one at a time. Maybe repeated every 2 hours as needed or as directed by a doctor.
  • Children under 6 years as a Doctor
Description

Active Ingredient: Menthol 1.1 mg.............oral anesthetic

Section 34088-5

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1

Keep this and all drugs out of the reach of children.

Section 50566-9

Stop use and consult a doctor if

  • sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.
Section 50569-3

Stop and consult a doctor if

  • sore throat is severe, or irritation, pain or redness last or worseness
  • sore mouh does not improve in 7 days
Section 51727-6

ascorbic acid (Vitamin C), aspartame, citric acid, extract of lemon balm, and other extracts herbs (elderflower, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme. wild thyme) isomalt, natural color (beta carotene), natural flavors

Section 51945-4

Section 53413-1

Questions? or to report and adverse event call: 1-833-552-1767

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses temporarily relieves:

ocassional minor irritation and pain associated with:

  • sore mouth
  • sore throat
Section 60561-8
  • Store in a cool and dry place
  • 5 calories per drop
  • Phenylketonurics, contains phenylalanine
  • Excessive use may have a laxative effect
  • Product maybe useful for diabetics

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. If sore mouth symptons does not improve in 7 days see your dentist or doctor promptly. These symptoms maybe serious.

Active Ingredient (55106-9)

Active Ingredient:

  • Menthol 1.1 mg.............oral anesthetic
Indications and Usage (34067-9)

Uses temporarily relieves:

ocassional minor irritation and pain associated with:

  • sore mouth
  • sore throat

Dosage and Administration (34068-7)

Directions

  • Adults and children 6 years and over: dissolve 2 drop slowly in mouth one at a time. Maybe repeated every 2 hours as needed or as directed by a doctor.
  • Children under 6 years as a Doctor
Section 34088-5 (34088-5)

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children.

Section 50566-9 (50566-9)

Stop use and consult a doctor if

  • sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.
Section 50569-3 (50569-3)

Stop and consult a doctor if

  • sore throat is severe, or irritation, pain or redness last or worseness
  • sore mouh does not improve in 7 days
Section 51727-6 (51727-6)

ascorbic acid (Vitamin C), aspartame, citric acid, extract of lemon balm, and other extracts herbs (elderflower, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme. wild thyme) isomalt, natural color (beta carotene), natural flavors

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? or to report and adverse event call: 1-833-552-1767

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses temporarily relieves:

ocassional minor irritation and pain associated with:

  • sore mouth
  • sore throat
Section 60561-8 (60561-8)
  • Store in a cool and dry place
  • 5 calories per drop
  • Phenylketonurics, contains phenylalanine
  • Excessive use may have a laxative effect
  • Product maybe useful for diabetics

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:42.083406 · Updated: 2026-03-14T23:03:53.608631