SPL v1
SPL
SPL Set ID 2fa086b4-3b0e-0df8-e063-6294a90a6769
Route
ORAL
Published
Effective Date 2025-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: oval Color: yellow Size: 25 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-05

Description

Uses temporarily relieves: ocassional minor irrititation and pain associated with sore mouth sore throat


Medication Information

Description

Uses temporarily relieves: ocassional minor irrititation and pain associated with sore mouth sore throat

Uses

Uses temporarily relieves:

ocassional minor irrititation and pain associated with

  • sore mouth
  • sore throat
Section 51945-4

Warnings

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

Directions
  • Adults and children 6 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by the doctor
  • Children under 6 years: as a doctor
Questions?

Questions? or to report an adverse event call 1-888-423-0139

Other Information

Other information

  • 5 calories per drop
  • Store in a cool and dry place
  • Phenylketonurics contains phenylalanine
  • Excessive use may have a laxative effect
  • Product may be useful for diabetics
Inactive Ingredients

Ascorbic acid,Citric acid, Elderflower, Horehound, Hyssop, Lemon balm, Linden flowers, Mallow, Peppermint, Sage, Thyme, Wild thyme, Aspartame, Isomalt, Betacarotene, Natural flavors

When Using This Product

When using this product

  • do not exceed recomended dosage
Indications & Usage Section

Uses temporarily relieves:

ocassional minor irritation and pain associated with

  • sore mouth
  • sore throat
Stop and Consult A Doctor If
  • sore throat is severe, or irritation, pain or redness lasts or worsens
  • sore mouth does not improve in 7 days.
If Pregnant Or Breast Feeding

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

Keep Out of the Reach of Children

Keep out of the reach of chilcren. In case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses (USES)

Uses temporarily relieves:

ocassional minor irrititation and pain associated with

  • sore mouth
  • sore throat
Section 51945-4 (51945-4)

Warnings

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

Directions
  • Adults and children 6 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by the doctor
  • Children under 6 years: as a doctor
Questions?

Questions? or to report an adverse event call 1-888-423-0139

Other Information (Other information)

Other information

  • 5 calories per drop
  • Store in a cool and dry place
  • Phenylketonurics contains phenylalanine
  • Excessive use may have a laxative effect
  • Product may be useful for diabetics
Inactive Ingredients

Ascorbic acid,Citric acid, Elderflower, Horehound, Hyssop, Lemon balm, Linden flowers, Mallow, Peppermint, Sage, Thyme, Wild thyme, Aspartame, Isomalt, Betacarotene, Natural flavors

When Using This Product (When using this product)

When using this product

  • do not exceed recomended dosage
Indications & Usage Section

Uses temporarily relieves:

ocassional minor irritation and pain associated with

  • sore mouth
  • sore throat
Stop and Consult A Doctor If (Stop and Consult a Doctor if)
  • sore throat is severe, or irritation, pain or redness lasts or worsens
  • sore mouth does not improve in 7 days.
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

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

Keep Out of the Reach of Children (Keep out of the reach of children)

Keep out of the reach of chilcren. In case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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