parodontax Active Gum Repair 1.1 mg/g

stannous fluoride · PASTE · Haleon US Holdings LLC

No Recall History

Plain English

parodontax Active Gum Repair is a paste containing stannous fluoride at 1.1 mg/g, taken dental. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name: parodontax Active Gum Repair
Generic Name: stannous fluoride
NDC Code (Product): 0135-0637
Manufacturer: Haleon US Holdings LLC
Strength: 1.1 mg/g
Dosage Form: PASTE
Route: DENTAL
Marketing Status
Application #: M022
Marketing Start: 01/04/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective14 reports

dyspnoea9 reports

oral discomfort9 reports

cough6 reports

fatigue6 reports

hypersensitivity6 reports

oral pain6 reports

swollen tongue6 reports

gingival bleeding5 reports

oral disorder5 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • aids in the prevention of dental cavities. • helps control bleeding gums. • helps interfere with harmful effects of plaque associated with gingivitis.

Dosage & Administration

Directions • adults and children 2 years of age and older: • brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Minimize swallowing. • to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established. • children under 2 years of age: Consult a dentist or doctor.

Warnings

Warnings Stop use and ask a dentist if • gingivitis, bleeding, or redness persists for more than 2 weeks. • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is parodontax Active Gum Repair used for?

parodontax Active Gum Repair contains stannous fluoride. It is a paste taken dental. Consult your doctor for specific uses.

Is parodontax Active Gum Repair a controlled substance?

parodontax Active Gum Repair is not classified as a controlled substance by the DEA.

What is the generic name for parodontax Active Gum Repair?

The generic name for parodontax Active Gum Repair is stannous fluoride. There are 12 other brand versions of stannous fluoride.

What is the NDC code for parodontax Active Gum Repair 1.1 mg/g?

The NDC (National Drug Code) for parodontax Active Gum Repair 1.1 mg/g is 0135-0637, listed by Haleon US Holdings LLC.

Product NDC

0135-0637

Package NDC

0135-0637-01

Other Stannous 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)