BEBELYN TEETHING- aconitum, calcarea phos, chamomilla,magnesia phos liquid

Bebelyn Teething by

Drug Labeling and Warnings

Bebelyn Teething by is a Homeopathic medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients & Purposes

• Active ingredients** (HPUS): Purposes*
• Aconitum 6C...................................................: Acute pain, with fever
• Calcarea phos 6C..................................................: Teething difficulty
• Chamomilla 5C, 15C...........................................: Teething, irritability
• Magnesia phos 6C......................................................: Teething pain

The letters “HPUS” indicate that this ingredient is officially included in the
Homeopathic Pharmacopeia of the United States

Uses*

• temporarily relieves the symptoms of
• simple restlessness
• wakeful irritability due to teething
• helps reduce gum redness and inflammation

Warnings

Stop use or ask a doctor if

• symptoms are accompanied by high fever (greater than 101°F (38°C)
• swelling or rash develops
• symptoms do not improve within 3 days or worsens

KEEP OUT OF THE REACH OF CHILDREN.

In case of an accidental overdose, seek medical help or contact a Poison Control right away.

Directions

• do not use more than directed
• children 3 months and older: 10 drops directly on the tongue or diluted in a little water, every 4 hours or as needed
• to preserve purity, do not touch the tip of dropper with the mouth

Other Information

• store at 68-77°F (20-25°C)
• protect from excessive heat or direct sun
• TAMPER EVIDENT: Do not use if neck band is torn, broken or missing.

Inactive ingredients

citric acid, glycerin USP, potassium sorbate, purified water.

Questions or comments?

1-866-359-3478 (M-F)
9 AM to 5 PM Eastern or www.pharmadel.com

Principal Display Panel

Bebelyn

Relieves / Alivia:

Teething pain/ Denticion

WITH CHAMOMILE / CON MANZANILLA

Homeopathic Remedy / Remedio Homeopático

Natural

3 months & older
3 meses y mayores

0.5 FL Oz (15 mL)

INGREDIENTS AND APPEARANCE

BEBELYN TEETHING 
aconitum, calcarea phos, chamomilla,magnesia phos liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-038
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE (UNII: 453COF7817) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE	6 [hp_C]
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	20 [hp_C]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	6 [hp_C]
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	6 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-038-01	1 in 1 CARTON	01/09/2017
1		1 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/09/2017

Labeler - Pharmadel LLC (030129680)