Ricola Throat Balm Caramel Pectin

Ricola Throat Balm Caramel Pectin
SPL v3
SPL
SPL Set ID 23cf2ba5-9d4d-409b-ab0e-a1d702f0bb15
Route
ORAL
Published
Effective Date 2022-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pectin (3.8 mg)
Inactive Ingredients
Sucrose Caramel

Identifiers & Packaging

Pill Appearance
Imprint: R Shape: oval Color: brown Size: 24 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-01

Description

Active ingredient (in two drops) Pectin 7.6 mg


Medication Information

Warnings and Precautions

Warnings

Do not use

  • ​in children under 6 years of age unless directed by a doctor.
Indications and Usage

Uses temporarily relieves:

occasional minor irritation and pain associated with

  • sore mouth
  • sore throat
Dosage and Administration

Directions

  • adults and children 6 years and older: dissolve 2 drops (one at a time) slowly in the mouth. Do not bite or chew. Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor
Description

Active ingredient (in two drops) Pectin 7.6 mg

Section 44425-7

Other Information

protect from heat and moisture

Section 50565-1

Keep out of reach of children.

Section 50569-3

Stop use and ask a doctor if

  • sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.
  • sore mouth symptoms do not improve in 7 days.
Section 51727-6

Inactive Ingredients: Caramel sugar syrup; cocoa butter; emulsifier (sunflower lecithin), extracts of bee balm, Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme) and rooibos; glucose syrup; glucose-fructose syrup; honey; humectant (glycerine); natural flavoring (caramel, echinacea purpurea fresh plant pressed juice powder, honey, menthol, peppermint, vanilla); salt; sugar

Section 51945-4

Section 55105-1

Purpose

Oral demulcent

Section 55106-9

Active ingredient (in two drops)

Pectin 7.6 mg


Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves:

occasional minor irritation and pain associated with

  • sore mouth
  • sore throat
Dosage and Administration (34068-7)

Directions

  • adults and children 6 years and older: dissolve 2 drops (one at a time) slowly in the mouth. Do not bite or chew. Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor
Warnings and Precautions (34071-1)

Warnings

Do not use

  • ​in children under 6 years of age unless directed by a doctor.
Section 44425-7 (44425-7)

Other Information

protect from heat and moisture

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50569-3 (50569-3)

Stop use and ask a doctor if

  • sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.
  • sore mouth symptoms do not improve in 7 days.
Section 51727-6 (51727-6)

Inactive Ingredients: Caramel sugar syrup; cocoa butter; emulsifier (sunflower lecithin), extracts of bee balm, Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme) and rooibos; glucose syrup; glucose-fructose syrup; honey; humectant (glycerine); natural flavoring (caramel, echinacea purpurea fresh plant pressed juice powder, honey, menthol, peppermint, vanilla); salt; sugar

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Oral demulcent

Section 55106-9 (55106-9)

Active ingredient (in two drops)

Pectin 7.6 mg


Advanced Ingredient Data


Raw Label Data

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