Arnicare Tablets

Arnicare Tablets
SPL v10
SPL
SPL Set ID 96a3e7ea-94ed-46b4-94d7-70b8cc68c688
Route
ORAL
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (9 [hp_C])
Inactive Ingredients
Croscarmellose Sodium Lactose Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: ; Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-07-11

Description

Active ingredient** (in each tablet) Arnica Montana 9C HPUS (2.5 mg) The letters "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Warnings and Precautions



Indications and Usage

Uses*

temporarily relieves minor muscle pain and stiffness due to:

  • minor injuries
  • overexertion
  • falls
  • reduces symptoms of bruising such as:
  • pain
  • swelling
  • discoloration
Dosage and Administration

Directions

Adults and children 6 years of age or older - At the onset of symptoms, dissolve 2 tablets under the tongue and repeat every hour for 2 more hours. Then, dissolve 2 tablets under the tongue every 6 hours until symptoms are relieved.

Children 2 to 5 years of age - Dissolve 2 tablets in 1 tablespoon for easier intake. Follow directions above.

Children under 2 years of age - Ask a doctor.

Description

Active ingredient** (in each tablet) Arnica Montana 9C HPUS (2.5 mg) The letters "HPUS" indicate that the component in this product is 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°F (30°C)

No known drug interactions

Pain Relief*

Swelling & Bruise from Injuries Muscle Pain*

Gentle on the Stomach

NSAID-Free

60 Meltaway Tablets unflavored

100 Meltawat Tablets unflavored

120 Meltaway Tablets unflavored

*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 7 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)



Distributed by Boiron, Inc.

Newtown Square, PA 19073

Made in France

Section 53414-9

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

Section 55105-1

Purpose*

Arnica montana 9C HPUS (2.5 mg) ... Relieves minor muscle pain & stiffness, swelling from injuries, discoloration from bruises

Section 55106-9

Active ingredient** (in each tablet)

Arnica Montana 9C HPUS (2.5 mg)

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


Structured Label Content

Indications and Usage (34067-9)

Uses*

temporarily relieves minor muscle pain and stiffness due to:

  • minor injuries
  • overexertion
  • falls
  • reduces symptoms of bruising such as:
  • pain
  • swelling
  • discoloration
Dosage and Administration (34068-7)

Directions

Adults and children 6 years of age or older - At the onset of symptoms, dissolve 2 tablets under the tongue and repeat every hour for 2 more hours. Then, dissolve 2 tablets under the tongue every 6 hours until symptoms are relieved.

Children 2 to 5 years of age - Dissolve 2 tablets in 1 tablespoon for easier intake. Follow directions above.

Children under 2 years of age - Ask a doctor.

Warnings and Precautions (34071-1)



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°F (30°C)

No known drug interactions

Pain Relief*

Swelling & Bruise from Injuries Muscle Pain*

Gentle on the Stomach

NSAID-Free

60 Meltaway Tablets unflavored

100 Meltawat Tablets unflavored

120 Meltaway Tablets unflavored

*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 7 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)



Distributed by Boiron, Inc.

Newtown Square, PA 19073

Made in France

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose*

Arnica montana 9C HPUS (2.5 mg) ... Relieves minor muscle pain & stiffness, swelling from injuries, discoloration from bruises

Section 55106-9 (55106-9)

Active ingredient** (in each tablet)

Arnica Montana 9C HPUS (2.5 mg)

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


Advanced Ingredient Data


Raw Label Data

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