Hyland's Quitter's Relief Digestion

Quitters Relief Digestion by

Drug Labeling and Warnings

Quitters Relief Digestion by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Homeopathic Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

QUITTERS RELIEF DIGESTION- activated charcoal,lycopodium clavatum spore,strychnos nux-vomica seed,matricaria chamomilla,cinchona officinalis bark,delphinium staphisagria seed,anamirta cocculus seed and ipecac tablet 
Hyland's

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Hyland's Quitter's Relief Digestion

Nausea, Heartburn, Constipation,Stomach Cramps, Gas, Diarrhea

Drug Facts

Active ingredients

• Active ingredients:

  Purpose

• Carbo Vegetabilis 12X HPUS:

  constipation, stomach cramps, nausea

• Chamomilla 6X HPUS:

  diarrhea, gas

• Cinchona Officinalis 6X HPUS:

  gas, constipation

• Cocculus Indicus 12X HPUS:

  gas, constipation

• Ipecacuanha 6X HPUS:

  stomach cramps, gas, diarrhea

• Lycopodium Clavatum 30X HPUS:

  heartburn, nausea, constipation

• Nux Vomica 30X HPUS (less than 0.0000000000016% Alkaloids, calculated):

  gas, constipation

• Staphysagria 12X HPUS:

  nausea, constipation associated with smoking cessation

"HPUS" indicates that the active ingredients are in the official Homeopathic

Pharmacopoeia of the United States.

Uses

■Temporarily relieves symptoms of digestive discomfort associated with smoking cessation, including:

■ nausea ■ heartburn ■ constipation

■ stomach cramps ■ gas ■ diarrhea

Warnings

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Do not use more than directed.

Consult a physician if symptoms persist for more than 7 days or worsen.

Keep this and all medications out of the reach of children.

In case of emergency or accidental overdose, contact a medical professional or

Poison Control Center immediately. Hyland’s may also be contacted for emergency

information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

• Adults ages 18 years and over:

  Dissolve 2 tablets under tongue every 15 minutes

  up to 4 doses, then every 4 hours until relieved.

Other information

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

Inactive ingredients

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

HOMEOPATHIC

NDC: 54973-4006-1

SINCE 1903

Hyland's

QUITTER’S RELIEF

Digestion*

GENTLE RELIEF FOR SMOKING CESSATION SYMPTOMS

Nausea, Heartburn, Constipation,

Stomach Cramps, Gas, Diarrhea

100 QUICK-DISSOLVING

TABLETS

NATURAL

RELIEF

*SEE NOTE ON BACK PANEL BELOW DRUG FACTS

QUITTERS RELIEF DIGESTION 
activated charcoal,lycopodium clavatum spore,strychnos nux-vomica seed,matricaria chamomilla,cinchona officinalis bark,delphinium staphisagria seed,anamirta cocculus seed and ipecac tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4006
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	12 [hp_X]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_X]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30 [hp_X]
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	6 [hp_X]
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	6 [hp_X]
ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U)	ANAMIRTA COCCULUS SEED	12 [hp_X]
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	6 [hp_X]
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
ACACIA (UNII: 5C5403N26O)

Product Characteristics
Color	white (Off White)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4006-1	1 in 1 CARTON	12/15/2020
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/15/2020	12/29/2021

Labeler - Hyland's (028570695)

Registrant - Standard Homeopathic Company (008316655)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-4006) , pack(54973-4006) , label(54973-4006)

Revised: 12/2021

Document Id: d450caaf-c872-7167-e053-2995a90a8e7b

34390-5

Set id: b1019900-45fe-3b8d-e053-2a95a90ab99d

Version: 2

Effective Time: 20211229