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OTC

Teething

arnica montana, trifolium pratense, calcarea carbonica, calcarea fluorica, calcarea phosphorica, chamomilla, kreosotum, silicea · Teething is an over-the-counter drug containing arnica montana, trifolium pratense, calcarea carbonica, calcarea fluorica, calcarea phosphorica, chamomilla, kreosotum, silicea, made by BioActive Nutritional, Inc..

Type
Over the counter
Drug class
Not classified
Route
Oral
Manufacturers
1

For temporary relief of pain due to teething and delayed teething.

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Active ingredients

Arnica Montana 3X, Trifolium Pratense 3X, Calcarea Carbonica 12X, Calcarea Fluorica 12X, Calcarea Phosphorica 12X, Chamomilla 12X, Kreosotum 12X, Silicea 12X

Purpose

INDICATIONS: For temporary relief of pain due to teething and delayed teething.

Uses

For temporary relief of pain due to teething and delayed teething.

Directions

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Warnings

If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in cool, dry place.

Keep out of reach of children

: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Inactive ingredients

Demineralized water, 25% Ethanol

Questions?

Distributed by: BioActive Nutritional, Inc. 1803 N. Wickham Rd. Melbourne, FL 32935 bioactivenutritional.com

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Liquid3 [hp_X]/mL / 3 [hp_X]/mL / 12 [hp_X]/mL / 12 [hp_X]/mL / 12 [hp_X]/mL / 12 [hp_X]/mL / 12 [hp_X]/mL / 12 [hp_X]/mLoral1

Manufacturers and labels

1 FDA label

  • BioActive Nutritional, Inc.Shown hereLabel 07/27/2016 · NDC 43857-0406Full label

Teething: common questions

What is Teething used for?
For temporary relief of pain due to teething and delayed teething.
Is Teething a prescription drug?
No. Teething is sold over the counter (OTC) without a prescription.
Who makes Teething?
BioActive Nutritional, Inc. lists Teething with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 07/27/2016 · Label text is shown as published by the manufacturer. Not medical advice

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