TEMPORARY FIBROMYALGIA PAIN AND DISCOMFORT RELIEF- atropa belladonna - bryonia alba root - causticum - phosphorus - strychnos nux-vomica seed - pulsatilla vulgaris - toxicodendron pubescens leaf - tablet, orally disintegrating

Temporary Fibromyalgia Pain and Discomfort Relief by

Drug Labeling and Warnings

Temporary Fibromyalgia Pain and Discomfort Relief by is a Homeopathic medication manufactured, distributed, or labeled by TRP Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Belladonna HPUS 6c, 12c, 18c
Bryonia HPUS 6c, 12c, 18c
Causticum HPUS 6c, 12c, 18c
Magnesia Phosphorica HPUS 6c,12c,18c
Nux Vomica HPUS 6c,12c,18c
Pulsatilla HPUS 6c,12c,18c
Rhus Tox HPUS 6c,12c,18c

HPUS indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

PURPOSE

Belladonna HPUS - Chronic discomfort, Fatigue
Bryonia HPUS - Difficulty moving, Stiff joints, Acute soreness
Causticum HPUS - Muscle and nerve soreness
Magnesia Phosphorica HPUS - Cramping, Fatigue
Nux Vomica HPUS - Sleeplessness, Irritable bowels
Pulsatilla HPUS - Migrating soreness
Rhus Tox HPUS - Soft tissue discomfort

Uses

According to homeopathic indications these ingredients provide temporary relief from symptoms of Fibromyalgia such as: Muscle soreness Fatigue Nerve / Soft tissue tenderness Multiple tender points after diagnosis by a physician.

* These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Keep out of reach of children

PREGNANCY OR BREAST FEEDING

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

Directions

• Suitable for adults and children 12 years and above.
• Dissolve entire tablet under tongue.
• Do not chew or swallow whole.
• Take 1 tablet 3 times a day or as directed by a physician.
• Use up to 6 times a day as needed.
• Take at least 10 minutes before or at least 10 minutes after eating or drinking.
• Children under the age of 12: consult a physician before use.

Other information

There are no known contraindications.

• Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side cool dark location. Temporary Fibromyalgia Pain and Discomfort Relief® Fast Dissolving TabletsTM are homeopathic dilutions, for details see www.thereliefproducts.com.

Inactive Ingredients

Advantol® 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.

Do not use if tamper evident seal is torn, broken or missing.

QUESTIONS

For more information and to order related products call toll free: 888-969-6855 or trpcompany.com

Do not use

Do not use if tamper evident seal is torn, broken or missing.

Stop use

Stop use and ask a doctor if:

Symptoms persist for more than 7 days or worsen, if new symptoms occur or if redness or swelling is present because these could be a sign of a serious illness.

Warning

USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN.

• This product is intended to complement, not replace, standard medical treatment.
• Initial worsening of symptoms may occur.
• A physician should always be consulted regarding Fibromyalgia to rule out serious causes.
• In case of overdose, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TEMPORARY FIBROMYALGIA PAIN AND DISCOMFORT RELIEF 
atropa belladonna - bryonia alba root - causticum - phosphorus - strychnos nux-vomica seed - pulsatilla vulgaris - toxicodendron pubescens leaf - tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17312-016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_C]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_C]
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	6 [hp_C]
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	6 [hp_C]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [hp_C]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_C]
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	6 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
MANNITOL (UNII: 3OWL53L36A)
SORBITOL (UNII: 506T60A25R)
CROSPOVIDONE (UNII: 68401960MK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
COPOVIDONE (UNII: D9C330MD8B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	DIAMOND	Size	13mm
Flavor		Imprint Code	TRP
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17312-016-14	1 in 1 PACKAGE	12/01/2011
1		70 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/01/2011

Labeler - TRP Company (105185719)