SYMPHYTUM OFFICINALE pellet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)
Available from:
Newton Laboratories, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Bone injuries; Eye injuries; Sprains; Bruises; Joint pain. Bone injuries; Eye injuries; Sprains; Bruises; Joint pain.
Authorization status:
unapproved homeopathic
Authorization number:
55714-7521-1

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SYMPHYTUM OFFICINALE- symphytum officinale pellet

Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for

safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Symphytum 7521P

INDICATIONS & USAGE SECTION

Bone injuries; Eye injuries; Sprains; Bruises; Joint pain.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as

directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive

persons begin with 1 pellet and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Symphytum officinale 15x, 10x, 200c, 30c.

OTC - PURPOSE SECTION

Bone injuries; Eye injuries; Sprains; Bruises; Joint pain.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose free) pellets.

QUESTIONS SECTION

newtonlabs.net - Questions? 1.800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

WARNINGS SECTION

WARNINGS:Keep out of reach of children. Do not use if tamper-evident seal is broken or missing.

If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-

feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

SYMPHYTUM OFFICINALE

symphytum officinale pellet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55714-7521

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CO MFREY RO O T (UNII: M9 VVZ0 8 EKQ) (COMFREY ROOT - UNII:M9 VVZ0 8 EKQ)

COMFREY ROOT

15 [hp_X] in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

SUCRO SE (UNII: C151H8 M554)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:55714-7521-

28 g in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n

Pro duc t

0 9 /0 1/20 11

Marketing Information

Newton Laboratories, Inc.

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 9 /0 1/20 11

Labeler -

Newton Laboratories, Inc. (788793610)

Registrant -

Newton Laboratories, Inc. (788793610)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Newto n Labo rato ries, Inc.

78 8 79 36 10

ma nufa c ture (55714-7521)

Revised: 12/2020

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