drug facts

drug facts
SPL v1
SPL
SPL Set ID 352c3aa1-0935-4fc7-b154-4ee1107c7357
Route
oral
Published
Effective Date 2015-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (80 mg)
Inactive Ingredients
fructose maltodextrin silicon dioxide sorbitol starch, corn stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: GPI;LB Shape: round Color: white Size: 13 mm Score: 1
Marketing Status
otc monograph final active Since 2015-07-16

Purpose

Anti-Gas

Description

Simethicone 80 mg, USP


Medication Information

Warnings


Active Ingredient

Simethicone 80 mg, USP



Uses

Relieves bloating and pressure commonly referred to as gas.



Purpose

Anti-Gas



Directions
  • Adults: Chew 1 or 2 tablets as needed after meals and at bedtime.
  • Do not exceed 6 tablets per day except under the advice and supervision of a physician.

Other Information
  • Store at room temperature.
  • Avoid high humidity.
  • Do not use if imprinted safety seal under cap is broken or missing.
Inactive Ingredients

Fructose, Maltodextrin, Natural and Artificial Spearmint Flavor, Silicon Dioxide, Sorbitol, Starch and Stearic Acid.



Description

Simethicone 80 mg, USP

Principal Display Panel

BLONIL

Simethicone 80 mg

Anti Gas

Relieves Gas Fast

  • Pressure
  • Bloating
  • Discomfort

100 CHEWABLE TABLETS 80mg Each

Questions?

If you have any questions or comments, or to report an adverse event, please contact +1 404 256 8817.



Section 53414-9

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



Keep This and All Drugs Out of the Reach of Children.



Structured Label Content

Warnings


Active Ingredient (Active ingredient (in each tablet))

Simethicone 80 mg, USP



Uses

Relieves bloating and pressure commonly referred to as gas.



Purpose

Anti-Gas



Directions
  • Adults: Chew 1 or 2 tablets as needed after meals and at bedtime.
  • Do not exceed 6 tablets per day except under the advice and supervision of a physician.

Other Information
  • Store at room temperature.
  • Avoid high humidity.
  • Do not use if imprinted safety seal under cap is broken or missing.
Inactive Ingredients (Inactive ingredients)

Fructose, Maltodextrin, Natural and Artificial Spearmint Flavor, Silicon Dioxide, Sorbitol, Starch and Stearic Acid.



Principal Display Panel

BLONIL

Simethicone 80 mg

Anti Gas

Relieves Gas Fast

  • Pressure
  • Bloating
  • Discomfort

100 CHEWABLE TABLETS 80mg Each

Questions?

If you have any questions or comments, or to report an adverse event, please contact +1 404 256 8817.



Section 53414-9 (53414-9)

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



Keep This and All Drugs Out of the Reach of Children. (Keep this and all drugs out of the reach of children.)



Advanced Ingredient Data


Raw Label Data

All Sections (JSON)