FDA Label for Diarrhea

View Indications, Usage & Precautions

Diarrhea Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients Hpus:



Cinchona officinalis (Calisaya bark) 8X

Bryonia (White bryony) 8X

Chamomilla (German chamomile) 8X

Colocynthis (Bitter apple) 8X

Ipecacuanha (Ipecac) 8X

Belladonna (Deadly nightshade) 8X


Purpose



diarrhea after eating fruit

cramp-like pain, colic, diarrhea

nausea after eating

cramps, colic, diarrhea

nausea, diarrhea

diarrhea and nauseousness


References



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 of diarrhea:

- diarrhea

- painful cramps

- nausea


Warnings




Otc - Stop Use



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


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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 every 4 hours, and reduce intake with improvement or as directed by a health professional.

AgeDose
Adults and children 12 years of age and older2 tablets
Children 2 to 11 years of age1 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




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