Spongia Tosta 6c

Spongia Tosta 6c
SPL v3
SPL
SPL Set ID 86e5946d-2564-e679-e053-2a91aa0ad055
Route
ORAL
Published
Effective Date 2024-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Spongia Officinalis Skeleton, Roasted (6 [hp_C])
Inactive Ingredients
Anhydrous Lactose Sucrose

Identifiers & Packaging

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

Description

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


Medication Information

Warnings and Precautions

Cough Relief Carton

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Indications and Usage

Cough Relief Uses*

temporarily relieves croupy, barking, or dry cough and hoarseness due to minor bronchial irritation

Tube Uses*

Relieves dry, barking cough *

Dosage and Administration

Cough Relief Carton

Adults and children 4 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every hour. Decrease frequency with improvement.

Children under 4 years of age: Ask a doctor.

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.

Description

Active ingredient ** (in each pellet) Spongia tosta 6C HPUS (**contains 0.443 mg of the active ingredient per 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

Cough Relief Carton

Cough Relief*

Croupy, Barking or Dry Cough Hoarseness

3 Tubes

Approx 80 pellets each

16 Doses per tube

Total 240 pellets

do not use if glued carton end flaps are open or if pellet dispenser seal is broken

contains 0.25 g of sugar per dose

Turn tube upside down. Twist until 5 pellets are dispensed. Remove the cap and use it to pour pellets under tongue.

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.

Section 50565-1

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

Cough Relief Carton

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Tube

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

Section 51727-6

lactose, sucrose

Section 51945-4

Section 53413-1

BoironUSA.com [email protected]

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

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

Relieves croupy, barking, or dry cough and hoarseness*

Section 55106-9

Active ingredient ** (in each pellet)

Spongia tosta 6C HPUS

(**contains 0.443 mg of the active ingredient per 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)

Cough Relief Uses*

temporarily relieves croupy, barking, or dry cough and hoarseness due to minor bronchial irritation

Tube Uses*

Relieves dry, barking cough *

Dosage and Administration (34068-7)

Cough Relief Carton

Adults and children 4 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue every hour. Decrease frequency with improvement.

Children under 4 years of age: Ask a doctor.

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.

Warnings and Precautions (34071-1)

Cough Relief Carton

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 42229-5 (42229-5)

Cough Relief Carton

Cough Relief*

Croupy, Barking or Dry Cough Hoarseness

3 Tubes

Approx 80 pellets each

16 Doses per tube

Total 240 pellets

do not use if glued carton end flaps are open or if pellet dispenser seal is broken

contains 0.25 g of sugar per dose

Turn tube upside down. Twist until 5 pellets are dispensed. Remove the cap and use it to pour pellets under tongue.

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.

Section 50565-1 (50565-1)

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)

Cough Relief Carton

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Tube

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

Section 51727-6 (51727-6)

lactose, sucrose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

BoironUSA.com [email protected]

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

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)

Relieves croupy, barking, or dry cough and hoarseness*

Section 55106-9 (55106-9)

Active ingredient ** (in each pellet)

Spongia tosta 6C HPUS

(**contains 0.443 mg of the active ingredient per 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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