Pyrogenium: Homeopathic Product Information

PYROGENIUM- rancid beef liquid
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.

INDICATIONS & USAGE SECTION

Fevers; Offensive discharges; Infected wounds

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC — ACTIVE INGREDIENT SECTION

Pyrogenium 200c, Pyrogenium 30c

OTC — PURPOSE SECTION

Fevers; Offensive discharges; Infected wounds

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

newtonlabs.net — Questions? 1.800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 — Conyers, GA 30013

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

package label
(click image for full-size original)

PYROGENIUM
pyrogenium liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-6444
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANCID BEEF (RANCID BEEF) RANCID BEEF 30 [hp_C] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55714-6444-1 30 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 01/01/2018
Labeler — Newton Laboratories, Inc. (788793610)
Registrant — Newton Laboratories, Inc. (788793610)
Establishment
Name Address ID/FEI Operations
Newton Laboratories, Inc. 788793610 manufacture (55714-6444)

Revised: 12/2020 Newton Laboratories, Inc.

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