Label: RELAX AM-PM- valerian root, passiflora, magnesium carbonate tablet
- NDC Code(s): 64175-991-25, 64175-991-45, 64175-991-90
- Packager: Foster Regal 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 18, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warning: Do not give to children under twelve except under the advice and supervision of a doctor. If you are pregnant or nursing a baby seek the advice of a health professional before using this product. Do not exceed recommended dosage. Consult a doctor if symptoms are more than mild or if they persist.
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DOSAGE & ADMINISTRATION
Directions: Adults and children 12 or more years of age.
Muscle Spasms - Take 1 or 2 tablets every 3 hours, until relief is obtained. To help prevent recurrence of muscle spasms, continue to take 1 or 2 tablets every 4 hours as needed.
Tension and Stress - Take 1 or 2 tablets every 4 hours, preferably with meals and at bedtime. To help prevent tension and stress take 1 or 2 tablets every 4 hours as needed.
Dosage should not exceed 12 tablets in any 24 hour period.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RELAX AM-PM
valerian root, passiflora, magnesium carbonate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64175-991 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 6 [hp_X] 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] Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MALTODEXTRIN (UNII: 7CVR7L4A2D) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color brown (brown with dark brown speckels) Score no score Shape ROUND (Tablet) Size 11mm Flavor Imprint Code 36 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64175-991-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/16/2011 2 NDC:64175-991-45 45 in 1 BOTTLE; Type 0: Not a Combination Product 11/16/2011 3 NDC:64175-991-25 250 in 1 BOTTLE; Type 0: Not a Combination Product 11/16/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/16/2011 Labeler - Foster Regal Laboratories (807396481) Registrant - Dee Cee Laboratories (034731893)
