Active Ingredient (In Each 5 Ml)
Simethicone 125 mg
Extra Strength Liquid
FDA Label NDC 68163-700
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc for the product Extra Strength (NDC 68163-700). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each 5 ml), purpose, uses, if pregnant or breast-feeding,, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigas
Uses
for the relief of pressure, bloating, and fullness commonly referred to as gas
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any sign or symptoms.
Directions
▪ shake well before using▪ do not take more than 20 mL in any 24-hour period except under the advise and supervision of a physician▪ measure only with dosing cup provided▪ do not use dosing cup with other products▪ mL = milliliter▪ adults: 5 mL or 10 mL in dosing cup provided as needed after meals and at bedtime.▪ do not exceed 4 softgels in 24 hours unless directed by a doctor
Other Information
- store at room temperature
- do not refrigerate
- protect from light, heat, and moisture
Inactive Ingredients
citric acid, carboxymethylcellulose sodium, glycerin, microcrystalline cellulose, natural pineapple coconut flavor, potassium sorbate, purified water, sodium benzoate, sorbitol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
Questions Or Comments?
Call 1-866-467-2748
Principal Display Panel
STARTS WORKING IN SECONDS
NDC# 68163-700-08
Relieves Gas, Bloating & Abdominal Discomfort
EXTRA STRENGTH
Gas relief liquid
Simethicone 125mg/Anti-Gas
FAST RELIEF
Relives Gas, bloating & Abdominal Discomfort
Pinacolada Flavor
Naturally Flavored
Dye & Sugar Free
48 DOSES
Dosage cup Included
8 FL OZ (237 mL)
IMPORTANT: Keep this carton for future reference on full labeling. |
Distributed by Lifelab Health LLC
6574 N. State Road # 7 361, Coconut Creek, FL 33073
MADE IN USA
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
* Please review the disclaimer below.
