Quit Smoking Symptom Relief Kit

Quit Smoking Symptom Relief Kit
SPL v1
SPL
SPL Set ID ffc34bc6-5de2-addb-e053-6294a90a25be
Route
ORAL
Published
Effective Date 2023-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lobelia Inflata (6 [hp_C]) Strychnos Nux-vomica Seed (30 [hp_C])
Inactive Ingredients
Sucrose Lactose, Unspecified Form

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 4 mm
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-07-05

Description

Active ingredients** (in each pellet) Lobelia inflata 6C HPUS (0.44 mg) (contains less than 10 -12 mg lobeline alkaloids per pellet) Nux vomica 30C HPUS (0.44 mg) (contains less than 10- 12 mg strychnine alkaloids 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

Indications and Usage

temporarily relieves symptoms associated with nicotine withdrawal such as:

  • nausea
  • irritability
  • digestive upset
Dosage and Administration

Directions Retain this carton for full directions.

Adults 21 years of age and older:

Nausea: At the onset of symptoms, dissolve 5 pellets of Lobelia inflata 6C under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Irritability or Digestive Upset: At the onset of symptoms, dissolve 5 pellets of Nux vomica 30C under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Description

Active ingredients** (in each pellet) Lobelia inflata 6C HPUS (0.44 mg) (contains less than 10 -12 mg lobeline alkaloids per pellet) Nux vomica 30C HPUS (0.44 mg) (contains less than 10- 12 mg strychnine alkaloids 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

do not use if glued 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 cap and pour pellets under the tongue

3 Tubes

Approx. 80 pellets each

Total 240 pellets

Meltaway pellets

Nausea Irritability Digestive Upset*

*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 doctor if symptoms 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)

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Purpose*

Lobelia inflata 6C HPUS (0.44 mg) ... Relieves nausea associated with nicotine withdrawal

Nux vomica 30C HPUS (0.44 mg) ... Relieves irritability and digestive upset associated with nicotine withdrawal

Section 55106-9

Active ingredients** (in each pellet)

Lobelia inflata 6C HPUS (0.44 mg) (contains less than 10 -12 mg lobeline alkaloids per pellet)

Nux vomica 30C HPUS (0.44 mg) (contains less than 10- 12 mg strychnine alkaloids 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)

temporarily relieves symptoms associated with nicotine withdrawal such as:

  • nausea
  • irritability
  • digestive upset
Dosage and Administration (34068-7)

Directions Retain this carton for full directions.

Adults 21 years of age and older:

Nausea: At the onset of symptoms, dissolve 5 pellets of Lobelia inflata 6C under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Irritability or Digestive Upset: At the onset of symptoms, dissolve 5 pellets of Nux vomica 30C under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Section 42229-5 (42229-5)

do not use if glued 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 cap and pour pellets under the tongue

3 Tubes

Approx. 80 pellets each

Total 240 pellets

Meltaway pellets

Nausea Irritability Digestive Upset*

*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 doctor if symptoms 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)

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose*

Lobelia inflata 6C HPUS (0.44 mg) ... Relieves nausea associated with nicotine withdrawal

Nux vomica 30C HPUS (0.44 mg) ... Relieves irritability and digestive upset associated with nicotine withdrawal

Section 55106-9 (55106-9)

Active ingredients** (in each pellet)

Lobelia inflata 6C HPUS (0.44 mg) (contains less than 10 -12 mg lobeline alkaloids per pellet)

Nux vomica 30C HPUS (0.44 mg) (contains less than 10- 12 mg strychnine alkaloids 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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