FORMULA 303- valerian root, passiflora, magnesium carbonate tablet

Formula 303 by

Drug Labeling and Warnings

Formula 303 by is a Homeopathic medication manufactured, distributed, or labeled by Dee Cee Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions: Adults and children 12 years of age and older, take as directed or as directed by your doctor. Do not exceed 12 tablets in a 24 hour period.

MUSCLE SPASM: As a muscle relaxant, two tablets every three hours until relief is obtained. Then two tablets with each meal and two at bedtime.

TENSION AND STRESS: As a relaxant, two tablets with each meal and two at bedtime.

WARNINGS

WARNING: If you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.

INACTIVE INGREDIENT

PURPOSE

Natural relief for muscle spasm, tension, and stress

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, seek professional assistance.

ACTIVE INGREDIENT

Each Tablet Contains: 6 parts Valerian Root (Quad Strength) 1X, 3 parts Passiflora (Quad Strength) 1X, 1 part Magnesium Carbonate 1X.

INDICATIONS & USAGE

MUSCLE SPASM: As a muscle relaxant, two tablets every three hours until relief is obtained. Then two tablets with each meal and two and bedtime.

TENSION AND STRESS: As a relaxant, two tablets with each meal and two at bedtime.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FORMULA 303 
valerian root, passiflora, magnesium carbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52301-303
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z)	PASSIFLORA INCARNATA FLOWER	3 [hp_X]  in 1 [hp_X]
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D)	MAGNESIUM CARBONATE	1 [hp_X]  in 1 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	6 [hp_X]  in 1 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	brown (brown with dark brown speckles)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	36
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52301-303-25	250 [hp_X] in 1 BOTTLE; Type 0: Not a Combination Product	09/19/1990
2	NDC: 52301-303-90	90 [hp_X] in 1 BOTTLE; Type 0: Not a Combination Product	09/19/1990
3	NDC: 52301-303-45	45 [hp_X] in 1 BOTTLE; Type 0: Not a Combination Product	09/19/1990
4	NDC: 52301-303-21	12 [hp_X] in 1 BAG; Type 0: Not a Combination Product	06/23/2017
5	NDC: 52301-303-60	60 [hp_X] in 1 BOTTLE; Type 0: Not a Combination Product	06/23/2017
6	NDC: 52301-303-30	300 [hp_X] in 1 BOTTLE; Type 0: Not a Combination Product	06/23/2017
7	NDC: 52301-303-12	120 [hp_X] in 1 BOTTLE; Type 0: Not a Combination Product	06/23/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/19/1990

Labeler - Dee Cee Laboratories (034731893)

Registrant - Dee Cee Laboratories (034731893)

Establishment
Name	Address	ID/FEI	Business Operations
Dee Cee Laboratories		034731893	manufacture(52301-303)