MEGA MENSES- apis mellifica, hamamelis virginiana, hydrastis canadensis, aletris farinosa, apocynum cannabinum, cinchona officinalis, cinnamomum, conium maculatum, helonias dioica, lilium tigrinum, millefolium, phosphorus, secale cornutum, thlaspi bursa-pastoris, trillium pendulum. 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.

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Mega 4786L

INDICATIONS & USAGE SECTION

Formulated for symptoms such as prolonged or heavy menses and pelvic pain.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up take 6 drops by mouth one to four times daily or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mellifica 6x, Hamamelis virginiana 6x, Hydrastis canadensis 6x, Aletris farinosa 15x, Apocynum cannabinum 15x, Cinchona officinalis 15x, Cinnamomum 15x, Conium maculatum 15x, Helonias dioica 15x, Lilium tigrinum 15x, Millefolium 15x, Phosphorus 15x, Secale cornutum 15x, Thlaspi bursa-pastoris 15x, Trillium pendulum 15x.

OTC - PURPOSE SECTION

Formulated for symptoms such prolonged or heavy menses and pelvic pain.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

newtonlabs.net - Questions? 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

MEGA MENSES
apis mellifica, hamamelis virginiana, hydrastis canadensis, aletris farinosa, apocynum cannabinum, cinchona officinalis, cinnamomum, conium maculatum, helonias dioica, lilium tigrinum, millefolium, phosphorus, secale cornutum, thlaspi bursa-pastoris, trillium pendulum. liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-4786
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	6 [hp_X] in 1 mL
CAPSELLA BURSA-PASTORIS (UNII: W0X9457M59) (CAPSELLA BURSA-PASTORIS - UNII:W0X9457M59)	CAPSELLA BURSA-PASTORIS	15 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X] in 1 mL
ALETRIS FARINOSA ROOT (UNII: O021JGR97X) (ALETRIS FARINOSA ROOT - UNII:O021JGR97X)	ALETRIS FARINOSA ROOT	15 [hp_X] in 1 mL
APOCYNUM CANNABINUM ROOT (UNII: 2F92409L9Z) (APOCYNUM CANNABINUM ROOT - UNII:2F92409L9Z)	APOCYNUM CANNABINUM ROOT	15 [hp_X] in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	15 [hp_X] in 1 mL
CINNAMON (UNII: 5S29HWU6QB) (CINNAMON - UNII:5S29HWU6QB)	CINNAMON	15 [hp_X] in 1 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	15 [hp_X] in 1 mL
CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U)	CHAMAELIRIUM LUTEUM ROOT	15 [hp_X] in 1 mL
LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI)	LILIUM LANCIFOLIUM WHOLE FLOWERING	15 [hp_X] in 1 mL
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	15 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X] in 1 mL
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	15 [hp_X] in 1 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	6 [hp_X] in 1 mL
TRILLIUM ERECTUM ROOT (UNII: AHW6F0T2X0) (TRILLIUM ERECTUM ROOT - UNII:AHW6F0T2X0)	TRILLIUM ERECTUM ROOT	15 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-4786-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/02/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/02/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-4786)