Sambucus Nigra 6c

Sambucus Nigra 6c
SPL v4
SPL
SPL Set ID 86c041ec-0905-2e5b-e053-2a91aa0a2b4c
Route
ORAL
Published
Effective Date 2020-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sambucus Nigra Flowering Top (6 [hp_C])
Inactive Ingredients
Sucrose Anhydrous Lactose

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 4 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1983-03-03

Description

Tube - Sambucus nigra 6C (**contains 0.443 mg of the active ingredient per pellet) Box - Sambucus nigra 6C HPUS (**contains 0.443 mg of the active ingredient in each pellet) 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

Tube - Hoarseness with painful cough and nasal congestion*

Box - temporarily relieves cold symptoms such as: painful cough, nasal congestion, hoarseness, loss of voice

Dosage and Administration

Tube - Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Box - Adults and children: Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Description

Tube - Sambucus nigra 6C (**contains 0.443 mg of the active ingredient per pellet) Box - Sambucus nigra 6C HPUS (**contains 0.443 mg of the active ingredient in each pellet) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 42229-5

Tube - Do not use if pellet dispenser seal is broken.

Contains approx 80 pellets.

How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.

*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.

Box - Do not use if glued carton end flaps are open or if pellet dispenser seal is broken.

3 Tubes approx 80 pellets 16 Doses per tube Total 240 pellets

How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed. Remove cap and pour pellets under the tongue.

Adults & Children

Non-drowsy

Meltaway Pellets

Cough & Cold Relief*

*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

Tube - Keep out of reach of children.

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

Section 50566-9

Tube - Stop use and ask a doctor if symptoms persist for more than 3 days or worsen

Box - Stop use and ask a doctor if cough lasts for more than 3 days, returns, or is accompanied by fever, rash, or persistent headache, as these could be signs of a serious condition.

Section 50570-1

Box - Do not use for persistent or chronic cough such as with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Section 51727-6

Tube - lactose, sucrose

Box - lactose, sucrose

Section 51945-4

Section 53413-1

Tube - 1-800-BOIRON-1 (1-800-264-7661),

BoironUSA.com [email protected]

Distributed by Boiron, Inc. Newtown Square, PA 19073

Box - 1-800-BOIRON-1 (1-800-264-7661),

BoironUSA.com [email protected]

Distributed by Boiron, Inc. Newtown Square, PA 19073

Section 53414-9

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

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

Section 55105-1

Box - Relieves hoarseness with painful cough and nasal congestion*

Section 55106-9

Tube - Sambucus nigra 6C (**contains 0.443 mg of the active ingredient per pellet)

Box - Sambucus nigra 6C HPUS (**contains 0.443 mg of the active ingredient in each pellet)

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)

Tube - Hoarseness with painful cough and nasal congestion*

Box - temporarily relieves cold symptoms such as: painful cough, nasal congestion, hoarseness, loss of voice

Dosage and Administration (34068-7)

Tube - Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Box - Adults and children: Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Section 42229-5 (42229-5)

Tube - Do not use if pellet dispenser seal is broken.

Contains approx 80 pellets.

How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.

*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.

Box - Do not use if glued carton end flaps are open or if pellet dispenser seal is broken.

3 Tubes approx 80 pellets 16 Doses per tube Total 240 pellets

How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed. Remove cap and pour pellets under the tongue.

Adults & Children

Non-drowsy

Meltaway Pellets

Cough & Cold Relief*

*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)

Tube - Keep out of reach of children.

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

Section 50566-9 (50566-9)

Tube - Stop use and ask a doctor if symptoms persist for more than 3 days or worsen

Box - Stop use and ask a doctor if cough lasts for more than 3 days, returns, or is accompanied by fever, rash, or persistent headache, as these could be signs of a serious condition.

Section 50570-1 (50570-1)

Box - Do not use for persistent or chronic cough such as with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Section 51727-6 (51727-6)

Tube - lactose, sucrose

Box - lactose, sucrose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Tube - 1-800-BOIRON-1 (1-800-264-7661),

BoironUSA.com [email protected]

Distributed by Boiron, Inc. Newtown Square, PA 19073

Box - 1-800-BOIRON-1 (1-800-264-7661),

BoironUSA.com [email protected]

Distributed by Boiron, Inc. Newtown Square, PA 19073

Section 53414-9 (53414-9)

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

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

Section 55105-1 (55105-1)

Box - Relieves hoarseness with painful cough and nasal congestion*

Section 55106-9 (55106-9)

Tube - Sambucus nigra 6C (**contains 0.443 mg of the active ingredient per pellet)

Box - Sambucus nigra 6C HPUS (**contains 0.443 mg of the active ingredient in each pellet)

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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