Arnica 30x Tablets

Arnica 30x Tablets
SPL v1
SPL
SPL Set ID 0682b0ee-eebb-c149-e063-6294a90a6293
Route
ORAL
Published
Effective Date 2023-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (30 [hp_X])
Inactive Ingredients
Magnesium Stearate Croscarmellose Sodium Lactose, Unspecified Form

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 9 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-10-01

Description

Active ingredients** (in each tablet) Arnica montana 30X 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

Indications and Usage

Uses*

temporarily relieves muscle pain and stiffness due to: minor injuries overexertion falls

reduces symptoms of bruising such as: pain swelling discoloration

Dosage and Administration

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

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

Children under 2 years of age: Ask a doctor.

Description

Active ingredients** (in each tablet) Arnica montana 30X 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 ends flaps are open or if the blister seal is broken

store below 86°F (30°C)

PAIN RELIEF*

Swelling & Bruises from Injuries Muscle Pain*

60 Meltaway Tablets, unflavored

Gentle on the stomach

NSAID-Free

No Known Drug Interactions

Non-Drowsy

Meltaway Tablets Require No Food or Water

*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)

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*

Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises

Section 55106-9

Active ingredients** (in each tablet)

Arnica montana 30X 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 muscle pain and stiffness due to: minor injuries overexertion falls

reduces symptoms of bruising such as: pain swelling discoloration

Dosage and Administration (34068-7)

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

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

Children under 2 years of age: Ask a doctor.

Section 42229-5 (42229-5)

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

store below 86°F (30°C)

PAIN RELIEF*

Swelling & Bruises from Injuries Muscle Pain*

60 Meltaway Tablets, unflavored

Gentle on the stomach

NSAID-Free

No Known Drug Interactions

Non-Drowsy

Meltaway Tablets Require No Food or Water

*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)

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*

Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises

Section 55106-9 (55106-9)

Active ingredients** (in each tablet)

Arnica montana 30X 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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