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

NDC Code(s): 17312-042-14
Packager: TRP Company

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated May 7, 2015

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

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 ...

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.
Close
PURPOSE
Belladonna HPUS - Chronic discomfort, Fatigue - Bryonia HPUS - Difficulty moving, Stiff joints, Acute soreness - Causticum HPUS - Muscle and nerve soreness - Magnesia Phosphorica HPUS ...

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
Close
Uses

Close
Warnings
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 ...
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 to rule out serious causes.
- In case of overdose, get medical help or contact a Poison Control Center right away.
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.
Close
Keep out of reach of children

Close
PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.
Close
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 ...
- 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.
- Homeopathic remedies may not be effective for everyone.
Close
Other information
Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects. Store in a cool dark ...
- Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.
- Store in a cool dark location.
Close
Inactive Ingredients
Advantol® 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.

Advantol® 300, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose.
Close
Do not use if tamper evident seal is torn, broken or missing.

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

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

Close

INGREDIENTS AND APPEARANCE

Product Information

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:17312-042
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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]

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:17312-042-14	1 in 1 PACKAGE	05/07/2015
1		50 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/07/2015

Labeler - TRP Company (105185719)

Registrant - TRP Company (105185719)

View All Sections

Find additional resources

(also available in the left menu)

Safety

Related Resources

More Info on this Drug

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

Number of versions: 1

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.