INDIGESTION: Homeopathic Product Information

INDIGESTION- lycopodium clavatum spore, silybum marianum seed, chelidonium majus, peumus boldus leaf and strychnos nux-vomica seed tablet, chewable
CVS PHARMACY

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.

Active ingredients HPUS:

Lycopodium clavatum (Clubmoss) 8X

Carduus marianus (Milk thistle) 8X

Chelidonium majus (Calandine) 8X

Boldo (Chilean sassafras) 8X

Nux vomica (Poison nut) 8X

Purpose

heartburn, nausea

burping acidity, nausea

upset stomach, bilious vomiting

slow digestion, digestion discomfort

indigestion from overeating

The letters ‘HPUS’ indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

*These statements have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with indigestion*:

– heartburn

– upset stomach

– digestive discomfort

Warnings

Stop use and ask a doctor if symptoms worsen or persist for more than 7 days.

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

Keep out of reach of children.

Directions

• Chew tablets and let dissolve in mouth.

• Do not use more than directed.

• Do not take with food.

• Repeat 3 times daily and reduce with improvement or as directed by a health professional.

Age Dose
Adults and children 12 years of age and older 2 tablets
Children 2 to 11 years of age 1 tablet

Other information

Store at room temperature (68 — 77F).

Do not use if the imprinted safety seal under cap is broken or missing.

Inactive ingredients

Lactose, magnesium stearate.

CARTON

image of carton label
(click image for full-size original)

INDIGESTION
lycopodium clavatum, carduus marianus, chelidonium majus, boldo, nux vomica tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-847
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE 8 [hp_X]
SILYBUM MARIANUM SEED (MILK THISTLE) SILYBUM MARIANUM SEED 8 [hp_X]
CHELIDONIUM MAJUS (CHELIDONIUM MAJUS) CHELIDONIUM MAJUS 8 [hp_X]
PEUMUS BOLDUS LEAF (PEUMUS BOLDUS LEAF) PEUMUS BOLDUS LEAF 8 [hp_X]
STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 8 [hp_X]
Inactive Ingredients
Ingredient Name Strength
LACTOSE
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-847-06 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, CHEWABLE in 1 BOTTLE This package is contained within the CARTON (59779-847-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 05/22/2014
Labeler — CVS PHARMACY (062312574)
Registrant — HOMEOLAB USA INC (202032533)
Establishment
Name Address ID/FEI Operations
HOMEOLAB USA INC 202032533 manufacture (59779-847)

Revised: 05/2014 CVS PHARMACY

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