Sepia 6X

Drug Labeling and Warnings

Drug Details [pdf]

SEPIA- sepia tablet 
Schwabe North America, 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.

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Sepia 6X

Active Ingredient:

Sepia 6X

Inactive Ingredients:
Cellulose
Croscarmellose sodium
Lactose
Magnesium stearate

Dosage and Administration:

Boericke and Tafel Brand: 

Directions: Adults or children over 2 years: Take 3 tablets 4-6 times a day. 

Allow to dissolve under tongue. 

Stop when symptoms are relieved.

Indications and Usage:

For temporary relief of menstrual pain.

Warnings:

Do not take this product for pain for more than 10 days (adult) or 5 days (children) unless directed by a doctor. 

If pain persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition. 

Pregnancy or Breast Feeding:

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

Keep Out of Reach of Children:

Keep out of reach of children.

Ask the Doctor:

Do not take this product for pain for more than 10 days (adult) or 5 days (children) unless directed by a doctor. 

If pain persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.

Overdosage:

In case of overdose, seek medical help or contact a Poison Control Center immediately.

Purpose:

For temporary relief of menstrual pain.

Package Label and Principal Display:  Boericke and Tafel Brand 21125933

21125933 02 Sepia 6X 100t

SEPIA 
sepia tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-5933
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	white (white tablet)	Score	no score
Shape	ROUND (B&T)	Size	6mm
Flavor		Imprint Code	B;T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-5933-2	100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2006	09/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2006	09/30/2019

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-5933)

Revised: 11/2017

Document Id: 2bdf51dc-7dee-438a-b40c-3f085b5178b8

34390-5

Set id: 30ff387c-927d-4adc-aa5b-658087cfc3ef

Version: 4

Effective Time: 20171109