RELAX AM-PM- valerian root, passiflora, magnesium carbonate tablet

Relax AM-PM by

Drug Labeling and Warnings

Relax AM-PM by is a Homeopathic medication manufactured, distributed, or labeled by Foster Regal Laboratories, Dee Cee Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

EACH TABLET CONTAINS:
6 parts Valerian Root (Quad-Strength) 1X, 3 parts Passiflora (Quad-Strength) 1X, 1 part Magnesium Carbonate 1X.

PURPOSE

For Relief of Muscle Spasms
Tension and Stress

KEEP OUT OF REACH OF CHILDREN

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. In case of accidental overdose seek professional assistance or contact a poison control center immediately.

INDICATIONS & USAGE

INDICATIONS: For temporary relief of muscle spasms, tension and stress.

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.

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

Lactose Monohydrate, Maltodextrin, Sodium Starch Glycolate Type A Potato, Stearic Acid, Silica

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RELAX AM-PM 
valerian root, passiflora, magnesium carbonate tablet

Product 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)