INDIGESTION REAL RELIEF: Homeopathic Product Information

INDIGESTION REAL RELIEF- lycopodium clavatum spore, silybum marianum seed, chelidonium majus, peumus boldus leaf and strychnos nux-vomica seed tablet, chewable
HOMEOLAB USA INC

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

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

PURPOSE

heartburn, nausea

burping acidity, nausea

upset stomach, bilious vomiting

slow digestion, digestion discomfort

indigestion from overeating

USES

This homeopathic medicine helps 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
Children under 2 years of age Ask a doctor

OTHER INFORMATION

Store at room temperature (68 — 77F).

Do not use if seal is broken or missing.

INACTIVE INGREDIENTS

Lactose, magnesium stearate.

CARTON

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

INDIGESTION REAL RELIEF
lycopodium clavatum, carduus marianus, chelidonium majus, boldo, nux vomica tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60512-6037
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 (SILYBUM MARIANUM SEED) 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:60512-6037-0 90 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/11/2012
Labeler — HOMEOLAB USA INC (202032533)
Establishment
Name Address ID/FEI Operations
HOMEOLAB USA INC 202032533 manufacture (60512-6037)

Revised: 11/2012 HOMEOLAB USA INC

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