Lemon Mint Drops

Lemon Mint Drops
SPL v1
SPL
SPL Set ID 1876df19-398a-23d8-e063-6394a90ae7e8
Route
ORAL
Published
Effective Date 2024-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.1 mg)
Inactive Ingredients
Flavone Tilia Cordata Flower Ascorbic Acid Aspartame Citric Acid Monohydrate Lemon Balm Oil Sambucus Nigra Flower Horehound Hyssopus Officinalis Whole Thyme Isomalt Malva Sylvestris Leaf Peppermint Sage Beta Carotene Wild Thyme

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: oval Color: yellow Size: 25 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-15

Description

Active ingredient Menthol 1.1 mg Oral anesthetic


Medication Information

Warnings and Precautions

Warnings

Sore throat warning: 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. If sore mouth symptons do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious .

Indications and Usage

Uses temporarily relieves:

ocasional minor irritation and pain associated with

  • sore mouth
  • sore throat

Dosage and Administration

Directions

  • Adults and children 6 years and over: dissolve 1 drop slowly in mouth. 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 and consult a doctor if

sore mouth does not improve in 7 days.

sore throat is severe, or irritation, pain or redness lasts or worsens.

Section 50569-3

Stop and consult a doctor if

  • sore mouth does not improve in 7 days.
  • sore throat is severe, or irritation, pain or redness lasts or worsens.
Section 51727-6

ascorbic acid (vitamin C), aspartame, citric acid, extract of lemon balm and others extract herbs (elder, 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: 1-800-910-68-74

Section 53414-9

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

Section 55105-1

Uses temporarily relieves:

ocasional minor irritation and pain associated with

  • sore mouth
  • sore throat
Section 55106-9

Active ingredient Menthol 1.1 mg

Oral anesthetic

Section 60561-8
  • 5 calories per dop
  • Store in a cool and dry place
  • Phenylketonurics, contains phenylalanine
  • Excessive use may have a laxative effect.
  • Product may be useful for diabetics

Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves:

ocasional minor irritation and pain associated with

  • sore mouth
  • sore throat

Dosage and Administration (34068-7)

Directions

  • Adults and children 6 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
  • Children under 6 years: as a doctor
Warnings and Precautions (34071-1)

Warnings

Sore throat warning: 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. If sore mouth symptons do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious .

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 and consult a doctor if

sore mouth does not improve in 7 days.

sore throat is severe, or irritation, pain or redness lasts or worsens.

Section 50569-3 (50569-3)

Stop and consult a doctor if

  • sore mouth does not improve in 7 days.
  • sore throat is severe, or irritation, pain or redness lasts or worsens.
Section 51727-6 (51727-6)

ascorbic acid (vitamin C), aspartame, citric acid, extract of lemon balm and others extract herbs (elder, 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: 1-800-910-68-74

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses temporarily relieves:

ocasional minor irritation and pain associated with

  • sore mouth
  • sore throat
Section 55106-9 (55106-9)

Active ingredient Menthol 1.1 mg

Oral anesthetic

Section 60561-8 (60561-8)
  • 5 calories per dop
  • Store in a cool and dry place
  • Phenylketonurics, contains phenylalanine
  • Excessive use may have a laxative effect.
  • Product may be useful for diabetics

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)