Drugplain

TheraBreath for Kids Anticavity Strawberry Splash .5 mg/mL

SODIUM FLUORIDE · RINSE · Church & Dwight Co., Inc.

No Recall HistoryCurrently in Shortage
Plain English

Therabreath For Kids Anticavity Strawberry Splash is an over-the-counter fluoride rinse used to help prevent tooth decay in children. You rinse your mouth with this strawberry-flavored solution as directed on the package to strengthen tooth enamel and protect against cavities.

Key Facts

Brand Name
TheraBreath for Kids Anticavity Strawberry Splash
Generic Name
SODIUM FLUORIDE
NDC Code (Product)
10237-256
Manufacturer
Church & Dwight Co., Inc.
Strength
.5 mg/mL
Dosage Form
RINSE
Route
ORAL
Marketing Status
Application #
M021
Marketing Start
01/01/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pyrexia170 reports
fatigue159 reports
nausea158 reports
vomiting156 reports
pain154 reports
weight increased154 reports
nasopharyngitis152 reports
type 2 diabetes mellitus145 reports
peripheral swelling144 reports
urticaria143 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use Aids in the prevention of dental cavities

Dosage & Administration

Directions Adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing. instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.

Warnings

Warnings Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is TheraBreath for Kids Anticavity Strawberry Splash used for?

Therabreath For Kids Anticavity Strawberry Splash is an over-the-counter fluoride rinse used to help prevent tooth decay in children. You rinse your mouth with this strawberry-flavored solution as directed on the package to strengthen tooth enamel and protect against cavities.

Is TheraBreath for Kids Anticavity Strawberry Splash a controlled substance?

TheraBreath for Kids Anticavity Strawberry Splash is not classified as a controlled substance by the DEA.

What is the generic name for TheraBreath for Kids Anticavity Strawberry Splash?

The generic name for TheraBreath for Kids Anticavity Strawberry Splash is SODIUM FLUORIDE. There are 12 other brand versions of SODIUM FLUORIDE.

What is the NDC code for TheraBreath for Kids Anticavity Strawberry Splash .5 mg/mL?

The NDC (National Drug Code) for TheraBreath for Kids Anticavity Strawberry Splash .5 mg/mL is 10237-256, listed by Church & Dwight Co., Inc..

Product NDC

10237-256

Package NDC

10237-256-10

Other Sodium Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)