说明与适用边界
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spl product data elements
TEENY TUMMY Gas Relief Drops Simethicone CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM ANHYDROUS CITRIC ACID MICROCRYSTALLINE CELLULOSE POLYSORBATE 60 POTASSIUM SORBATE WATER SODIUM BENZOATE SORBITAN MONOSTEARATE SORBITOL XANTHAN GUM DIMETHICONE DIMETHICONE
活性成分 / Active ingredient
Active ingredient (in each 0.3 mL) Simethicone 20 mg
用途 / Purpose
Purpose Antigas
适应证 / Indications and usage
Uses relieves the symptoms referred to as gas
警告 / Warnings
Warnings In case of overdose seek medical help immediately or contact Poison Control Center right away (800)222-1222 For adverse reactions contact the FDA at www.fda.gov or 1(888)463-6332 Keep this and all medications out of the reach of children
儿童安全 / Keep out of reach of children
Keep this and all medications out of the reach of children
用法用量原文 / Dosage and administration
Directions • shake well before using • all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician • do not exceed 12 doses per day • fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek • dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids • clean dropper well after each use and replace original cap on bottle Age (years) Weight (lbs) Dose infants under 2 under 24 0.3 mL children over 2 over 24 0.6 mL
dosage and administration table
<table width="100%"><col width="42%"/><col width="36%"/><col width="22%"/><tbody><tr><td align="center" styleCode="Botrule Lrule Toprule" valign="top"><paragraph><content styleCode="bold">Age (years)</content></paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Weight (lbs)</content></paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule" valign="top"><paragraph><content styleCode="bold">Dose</content></paragraph></td></tr><tr><td align="center" styleCode="Botrule Lrule" valign="top"><paragraph>infants under 2</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule" valign="top"><paragraph>under 24</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule" valign="top"><paragraph>0.3 mL</paragraph></td></tr><tr><td align="center" styleCode="Botrule Lrule" valign="top"><paragraph>children over 2</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule" valign="top"><paragraph>over 24</paragraph></td><td align="center" styleCode="Botrule Lrule Rrule" valign="top"><paragraph>0.6 mL</paragraph></td></tr></tbody></table>
储存 / Storage and handling
Other information TAMPER-EVIDENT : Do not use if printed seal under cap is broken or punctured store at room temperature do not freeze see bottom panel for lot number and expiration date
辅料 / Inactive ingredients
Inactive ingredients Carboxymethylcellulose sodium, Citric acid, Flavor strawberry, Microcrystalline cellulose, Polysorbate 60, Potassium sorbate, Purified water, Sodium benzoate, Sorbitan monostearate, Sorbitol solution, Xanthan gum. Questions or comments ? DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179
questions
Questions or comments ? DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP. MIAMI, FL 33179
package label principal display panel
image description 5 6 7
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 5 / 20260213
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.