avespan-muyme mint 2025

avespan-muyme mint 2025
SPL v1
SPL
SPL Set ID 312ae88d-7ea4-b3e0-e063-6294a90a99e5
Route
dental
Published
Effective Date 2025-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.62 mg)
Inactive Ingredients
sodium cocoyl isethionate cellulose, microcrystalline sodium bicarbonate peppermint illite bentonite sodium alginate citric acid menthol starch, tapioca vanilla acacia sorbitol steviol

Identifiers & Packaging

Pill Appearance
Imprint: NONE Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-03-25
Purpose

Anti-cavity

Description

Sodium Fluoride 0.62mg (28 mg flouride ion)

Medication Information

Warnings
  • When using this product, if irritation or sensitivity occurs discontinue use.
  • Keep out of the reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Purpose

Anti-cavity

Directions
  • Adults and children 6 years of age and older; chew one tablet briefly and brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Do not swallow the tablet.
  • Supervise children under 6 years of age for brushing and rinsing.
Other Information

Store at 25-30°C (68-77°F). Protect from excessive moisture.

Inactive Ingredients

Sorbitol, Microcrystalline Cellulose, Sodium Bicarbonate, Mentha Piperita

(Peppermint) Oil, Sodium CocoylIsethionate, Tapioca Starch, Citric Acid,

Illite Clay, Organic Menthol, Stevia, Gum Arabic, Bentonite Clay, Vanilla

Bean, Sodium Alginate

Description

Sodium Fluoride 0.62mg (28 mg flouride ion)

Use

aids in the prevention of dental cavities

Section 50565-1

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Section 50567-7

When using this product, if irritation or sensitivity occurs discontinue use.

Active Ingredient(s)

Sodium Fluoride 0.62mg (28 mg flouride ion)

Package Label Principal Display Panel

Mint 10 Tablets; NDC: 74355-666-11

Structured Label Content

Warnings
  • When using this product, if irritation or sensitivity occurs discontinue use.
  • Keep out of the reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Purpose

Anti-cavity

Directions
  • Adults and children 6 years of age and older; chew one tablet briefly and brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Do not swallow the tablet.
  • Supervise children under 6 years of age for brushing and rinsing.
Other Information (Other information)

Store at 25-30°C (68-77°F). Protect from excessive moisture.

Inactive Ingredients (Inactive ingredients)

Sorbitol, Microcrystalline Cellulose, Sodium Bicarbonate, Mentha Piperita

(Peppermint) Oil, Sodium CocoylIsethionate, Tapioca Starch, Citric Acid,

Illite Clay, Organic Menthol, Stevia, Gum Arabic, Bentonite Clay, Vanilla

Bean, Sodium Alginate

Use

aids in the prevention of dental cavities

Section 50565-1 (50565-1)

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Section 50567-7 (50567-7)

When using this product, if irritation or sensitivity occurs discontinue use.

Active Ingredient(s)

Sodium Fluoride 0.62mg (28 mg flouride ion)

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Mint 10 Tablets; NDC: 74355-666-11

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:46.976219 · Updated: 2026-03-14T23:08:04.646392