Arnicare Leg Cramps Pm

Arnicare Leg Cramps Pm
SPL v3
SPL
SPL Set ID 051a4e17-c665-ec4d-e063-6294a90aabe6
Route
ORAL
Published
Effective Date 2024-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Passiflora Incarnata Top (3 [hp_X]) Copper (4 [hp_C]) Arnica Montana (6 [hp_C]) Magnesium Cation (9 [hp_C]) Strychnos Nux-vomica Seed Claviceps Purpurea Sclerotium
Inactive Ingredients
Magnesium Stearate Croscarmellose Sodium Lactose, Unspecified Form

Identifiers & Packaging

Pill Appearance
Imprint: Boiron Shape: round Color: white Size: 9 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-09-11

Description

Active ingredients** (in each tablet) Arnica montana 6C HPUS (0.42 mg) Cuprum metallicum 4C HPUS (0.42 mg) Magnesia phosphorica 6C HPUS (0.42 mg) Nux vomica 6C HPUS (0.42 mg) (contains less than 10 -13 mg strychnine alkaloids) Passiflora incarnata 3X HPUS (0.42 mg) Secale cornutum 9C HPUS (0.42 mg) (contains less thank 10 -20 mg ergotamine alkaloids) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Indications and Usage

Uses* temporarily relieves nighttime cramps in legs, thighs, calves, feet, and toes with accompanying occasional disrupted sleep

Dosage and Administration
  • Adults and children 18 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth at bedtime and during the night if needed, for up to 6 times per 24 hours.
  • Children under 18 years of age: Not recommended.
Description

Active ingredients** (in each tablet) Arnica montana 6C HPUS (0.42 mg) Cuprum metallicum 4C HPUS (0.42 mg) Magnesia phosphorica 6C HPUS (0.42 mg) Nux vomica 6C HPUS (0.42 mg) (contains less than 10 -13 mg strychnine alkaloids) Passiflora incarnata 3X HPUS (0.42 mg) Secale cornutum 9C HPUS (0.42 mg) (contains less thank 10 -20 mg ergotamine alkaloids) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 42229-5

do not use if glued carton end flaps are open or if the blister seal is broken

store below 86 oF (30 oC)

60 Meltaway Tablets, unflavored

120 Meltaway Tablets, unflavored

Nighttime Leg Cramp Relief*

Plant-Based & Other Pure Actives

Non-Habit Forming

No Known Drug Interactions

No Artificial Sweeteners, Flavors, Colors or Preservatives

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.

Section 51727-6

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4

Section 53413-1

Questions or comments?

Arnicare.com

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Section 53414-9

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

Section 55105-1

Purpose*

Arnica montana 6C HPUS ... Temporarily relieves minor muscle pain

Cuprum metallicum 4C HPUS ... Relieves sudden muscle cramps in the legs, calves, feet, and toes

Magnesia phosphorica 6C HPUS ... Relieves flashing pain and cramps in the calves and thighs, at night

Nux vomica 6C HPUS ... Relieves cramps in the legs, thighs, calves and toes, at night

Passiflora incarnata 3X HPUS ... Helps to fall back asleep

Secale cornutum 9C HPUS ... Relieves leg cramps at night

Section 55106-9

Active ingredients** (in each tablet)

Arnica montana 6C HPUS (0.42 mg)

Cuprum metallicum 4C HPUS (0.42 mg)

Magnesia phosphorica 6C HPUS (0.42 mg)

Nux vomica 6C HPUS (0.42 mg) (contains less than 10 -13 mg strychnine alkaloids)

Passiflora incarnata 3X HPUS (0.42 mg)

Secale cornutum 9C HPUS (0.42 mg) (contains less thank 10 -20 mg ergotamine alkaloids)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Structured Label Content

Indications and Usage (34067-9)

Uses* temporarily relieves nighttime cramps in legs, thighs, calves, feet, and toes with accompanying occasional disrupted sleep

Dosage and Administration (34068-7)
  • Adults and children 18 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth at bedtime and during the night if needed, for up to 6 times per 24 hours.
  • Children under 18 years of age: Not recommended.
Section 42229-5 (42229-5)

do not use if glued carton end flaps are open or if the blister seal is broken

store below 86 oF (30 oC)

60 Meltaway Tablets, unflavored

120 Meltaway Tablets, unflavored

Nighttime Leg Cramp Relief*

Plant-Based & Other Pure Actives

Non-Habit Forming

No Known Drug Interactions

No Artificial Sweeteners, Flavors, Colors or Preservatives

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.

Section 51727-6 (51727-6)

croscarmellose sodium, lactose, magnesium stearate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Arnicare.com

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661)

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose*

Arnica montana 6C HPUS ... Temporarily relieves minor muscle pain

Cuprum metallicum 4C HPUS ... Relieves sudden muscle cramps in the legs, calves, feet, and toes

Magnesia phosphorica 6C HPUS ... Relieves flashing pain and cramps in the calves and thighs, at night

Nux vomica 6C HPUS ... Relieves cramps in the legs, thighs, calves and toes, at night

Passiflora incarnata 3X HPUS ... Helps to fall back asleep

Secale cornutum 9C HPUS ... Relieves leg cramps at night

Section 55106-9 (55106-9)

Active ingredients** (in each tablet)

Arnica montana 6C HPUS (0.42 mg)

Cuprum metallicum 4C HPUS (0.42 mg)

Magnesia phosphorica 6C HPUS (0.42 mg)

Nux vomica 6C HPUS (0.42 mg) (contains less than 10 -13 mg strychnine alkaloids)

Passiflora incarnata 3X HPUS (0.42 mg)

Secale cornutum 9C HPUS (0.42 mg) (contains less thank 10 -20 mg ergotamine alkaloids)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Advanced Ingredient Data


Raw Label Data

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