Label: FORMULA 303- valerian root, passiflora, magnesium carbonate tablet
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NDC Code(s):
52301-303-12,
52301-303-21,
52301-303-25,
52301-303-30, view more52301-303-45, 52301-303-60, 52301-303-90
- Packager: Dee Cee Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated December 13, 2022
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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
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FORMULA 303
valerian root, passiflora, magnesium carbonate tabletProduct 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] MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE 1 [hp_X] VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 6 [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 in 1 BOTTLE; Type 0: Not a Combination Product 09/19/1990 2 NDC:52301-303-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/19/1990 3 NDC:52301-303-45 45 in 1 BOTTLE; Type 0: Not a Combination Product 09/19/1990 4 NDC:52301-303-21 12 in 1 BAG; Type 0: Not a Combination Product 06/23/2017 5 NDC:52301-303-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 06/23/2017 6 NDC:52301-303-30 300 in 1 BOTTLE; Type 0: Not a Combination Product 06/23/2017 7 NDC:52301-303-12 120 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)