Gentle Naturals description, usages, side effects, indications, overdosage, supplying and lots more!

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Gentle Naturals

Insight Pharmaceuticals

Gentle Naturals Homeopathic Teething Drops


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
Chamomilla (Chamomile) 3X, 6X, 12X, 30X pain and sensitivity of teething, calming
Calcarea Phosphorica (Calcium Phosphate) 6X pain and sensitivity of teething
Kali Phosphoricum (Potassium Phosphate) 6X pain in mouth and gums
Magnesia Phosphorica (Magnesium Phosphate) 6X pain and sensitivity of teething
Staphysagria (Delphinium Staphisagria) 9X pain and sensitivity of teething

Gentle Naturals Uses

temporarily relieves sore gums and restlessness and irritability due to teething in infants and children 4 months and older

Warnings

Do not use more than directed.

When using this product

  • fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms do not go away, advise your physician or dentist.

Stop use and ask a physician or dentist if

  • sore mouth symptoms do not get better in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash or fever develops

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

Directions

  • children and infants over 4 months of age, place one half dropper (0.5mL) under the tongue every 2 hours. Once symptoms improve reduce to 4 times daily.
  • for infants under 4 months of age, ask a physician or dentist.

Gentle Naturals Other information

  • Do not use if white neck band printed with "sealed for your protection" is broken or missing.
  • Store tightly closed at room temperature 15°-25°C (59°-77°F).
  • Keep carton for full drug facts.

Inactive ingredients

citric acid, glycerin, purified water, sodium benzoate

Questions?

call 1-800-344-7239 or visit our website at www.gentlenaturals.com

Distributed by:

INSIGHT Pharmaceuticals Corp. Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Carton

Gentle
Naturals
®

Homeopathic
Teething Drops

Relieves Teething Pain
100% Natural with Chamomile
with No Known Side Effects

1 FL OZ (29.6 mL)

Gentle Naturals

Gentle Naturals

Matricaria Recutita, Tribasic Calcium Phosphate, Potassium Phosphate, Dibasic, Magnesium Phosphate, Dibasic Trihydrate, and Delphinium Staphisagria Seed LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63736-318
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Matricaria Recutita MATRICARIA RECUTITA 30 [hp_X]
TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION 6 [hp_X]
potassium phosphate, dibasic PHOSPHATE ION 6 [hp_X]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE MAGNESIUM CATION 6 [hp_X]
DELPHINIUM STAPHISAGRIA SEED DELPHINIUM STAPHISAGRIA SEED 9 [hp_X]

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
water
SODIUM BENZOATE

Product Characteristics

Color
WHITE (Clear)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 1 in 1 BOX
3 NDC:63736-318-24 24 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2010-06-20


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