gas relief

gas relief
SPL v3
SPL
SPL Set ID 531b9850-c93e-4a0c-bd1c-7da33d752d80
Route
oral
Published
Effective Date 2018-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dimethicone (80 mg)
Inactive Ingredients
dextrose sucrose maltodextrin microcrystalline cellulose peppermint silicon dioxide 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 1999-11-04

Purpose

Antiflatulent

Description

(in each chewable tablet) Simethicone 80 mg


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 physician
Other Information
  • store at room temperature 15-30 °C (59-86 °F)
  • protect from moisture
Inactive Ingredients

dextrose, dipac sugar, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid

Description

(in each chewable tablet) Simethicone 80 mg

Section 50565-1

Keep out of reach of children

Drug Facts

Package Label

DC: 17714-019-01  – 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 631-981-4600, 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 physician
Other Information
  • store at room temperature 15-30 °C (59-86 °F)
  • protect from moisture
Inactive Ingredients

dextrose, dipac sugar, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid

Section 50565-1 (50565-1)

Keep out of reach of children

Drug Facts

Package Label

DC: 17714-019-01  – 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 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)