gas relief simethicone

gas relief simethicone
SPL v2
SPL
SPL Set ID f4be1c0d-01fc-4681-9068-905ed3184534
Route
oral
Published
Effective Date 2017-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (80 mg)
Inactive Ingredients
dextrose sucrose maltodextrin peppermint sorbitol stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: AP;019 Shape: round Color: white Size: 13 mm Score: 1
Marketing Status
otc monograph final active Since 2011-03-01
Purpose

Antiflatulent

Description

.

Medication Information

Warnings

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

Uses

relieves

  • bloating
  • pressure
  • discomfort of gas which can be caused by certain foods or air swallowing
Purpose

Antiflatulent

Directions
  • chew thoroughly 1 to 2 tablets as needed after meals and at bed time.
  • do not exceed 6 tablets per day unless directed by a doctor
Other Information
  • store at room temperature 15-30 °C (59-86 °F)
  • protect from moisture
Inactive Ingredients

dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid

Description

.

Section 50565-1

Keep out of reach of children

Drug Facts

.

Package Label

NDC:  54738-518-01

– 100 CHEWABLE

TABLETS

Active Ingredient

(in each chewable tablet)

Simethicone 80 mg

Questions Or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 804-270-4498, 8.30 am – 4.30 pm EST Monday - Friday

Structured Label Content

Warnings

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

Uses

relieves

  • bloating
  • pressure
  • discomfort of gas which can be caused by certain foods or air swallowing
Purpose

Antiflatulent

Directions
  • chew thoroughly 1 to 2 tablets as needed after meals and at bed time.
  • do not exceed 6 tablets per day unless directed by a doctor
Other Information
  • store at room temperature 15-30 °C (59-86 °F)
  • protect from moisture
Inactive Ingredients

dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid

Section 50565-1 (50565-1)

Keep out of reach of children

Drug Facts

.

Package Label

NDC:  54738-518-01

– 100 CHEWABLE

TABLETS

Active Ingredient

(in each chewable tablet)

Simethicone 80 mg

Questions Or Comments (Questions or Comments)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 804-270-4498, 8.30 am – 4.30 pm EST Monday - Friday

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:26.115731 · Updated: 2026-03-14T22:54:54.026912