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Drug Facts
Distributed by: Arymar Inc.
8004 NW 154 St. # 343
Miami Lakes FL 33016
Gas Relief Drops
FDA Label NDC 70570-0197
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Arymar Inc. for the product Gas Relief Drops (NDC 70570-0197). 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 other, active ingredient (in each 0.3ml), purpose, uses, otc - when using, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 0.3Ml)
Simethicone 20mg
Purpose
Antigas
Uses
relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods
Otc - When Using
when using this product do not exceed 12 doses per day
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children
In case pf overdose get medical help or contact a poison control center right away.
Directions
- shake well before using.
- all dosages may be repeated as needed, after meals and at bedtime.
- fill enclosed dropper to recommended dosage level.
- dispense liquid slowly into baby's mouth, toward the inner cheek.
- may mix with 1 oz. of cool water, infant formula or other suitable liquids.
- clean dropper after each use and replace original cap.
| age (yr) | weight (lb) | dose |
|---|---|---|
| infants under 2 | under 24 | 0.3mL |
| children 2 and over | over 24 | 0.6 mL |
Other Information
Store between 15°-30°C (59°-86° F). Avoid exposing bottle to excessive heat and direct sunlight. Do not accept if safety seal is broken or missing. Keep box for information.
Inactive Ingredients
Anise oil, carbomer, glycerin, methylparaben, propylparaben, purified water, sodium citrate and sucralose.
Principal Display Panel - 30 Ml Bottle Carton
Arymar®
Gas Relief
Drops
Simethicone - Anti-Gas
Safe enough to use
every feeding
● No Alcohol ● No Saccharin
● No Artificial Colors
● No Artificial Flavors
1 Fl. Oz. (30 ml)
Arymar®
Principal Display Panel (30 ml Bottle Carton)
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