PMS (apis mellifica, chamomilla, cimicifuga racemosa, cuprum metallicum, ignatia amara, kali iodatum, magnesia phosphorica, oophorinum- suis, platinum metallicum, sepia, thuja occidentalis spray

PMS by

Drug Labeling and Warnings

PMS by is a Homeopathic medication manufactured, distributed, or labeled by Liddell Laboratories, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

(in each drop): 9.09% of Apis mellifica 200C, Chamomilla 12X, Cimicifuga racemosa 6X, Cuprum metallicum 12X, Ignatia amara 6X, Kali iodatum 200C, Magnesia phosphorica 9X, Oophorinum (suis) 30C, Platinum metallicum 12X, Sepia 9X, Thuja occidentalis 200C.

USES:

May temporarily relieves these symptoms associated with PMS:

irregular periods
pain and cramps
backache
fluid retention
mood swings
anxiety and tension
irritability**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur.

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

If pregnant or breast feeding, ask a doctor before using product.

OTHER INFORMATION: Store at room temperature.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

DIRECTIONS:

Adults and children over 12:  Spray twice under the tongue three times per day.  For severe symptoms, dosage may be taken up to six times the first day.

Children 12 and under:  Consult a doctor prior to use.

KEEP OUT OF REACH OF CHILDREN:

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

INACTIVE INGREDIENTS:

Organic alcohol 20%v/v, Purified water

USES:

May temporarily relieves these symptoms associated with PMS:

irregular periods
pain and cramps
backache
fluid retention
mood swings
anxiety and tension
irritability**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

QUESTIONS:

LIDDELL LABORATORIES

201 APPLE BLVD.

WOODBINE, IA 51579

www.liddell.net

1-800-460-7733

PACKAGE LABEL DISPLAY:

ORAL SPRAYS
LIDDELL LABORATORIES
EST. 1994

08PmS

Premenstrual

Syndrome

Relieves PMS symptoms:

irregular periods, pain, cramps,

backache, fluid retention,

mood swings, anxiety,

tension + irritability.

HOMEOPATHIC

DOCTOR FORMULATED
Readily absorbed. Safe.

No known side effects. Easy to use.

1.0 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

PMS 
apis mellifica, chamomilla, cimicifuga racemosa, cuprum metallicum, ignatia amara, kali iodatum, magnesia phosphorica, oophorinum (suis), platinum metallicum, sepia, thuja occidentalis spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50845-0109
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z)	APIS MELLIFERA	200 [hp_C]  in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	12 [hp_X]  in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	6 [hp_X]  in 1 mL
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	12 [hp_X]  in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	6 [hp_X]  in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	POTASSIUM IODIDE	200 [hp_C]  in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	9 [hp_X]  in 1 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O)	SUS SCROFA OVARY	30 [hp_C]  in 1 mL
PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY)	PLATINUM	12 [hp_X]  in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	9 [hp_X]  in 1 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	200 [hp_C]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50845-0109-2	1 in 1 CARTON	09/06/2016
1	NDC: 50845-0109-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/18/2011

Labeler - Liddell Laboratories, Inc. (832264241)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(50845-0109) , api manufacture(50845-0109) , label(50845-0109) , pack(50845-0109)