RELAX AM-PM- valerian root, passiflora, magnesium carbonate tablet 
Foster Regal Laboratories

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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Relax AM-PM

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

For Relief of Muscle Spasms
Tension and Stress

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

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.

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.

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

Image of Label

RELAX AM-PM 
valerian root, passiflora, magnesium carbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64175-991
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER3 [hp_X]
MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
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
Colorbrown (brown with dark brown speckels) Scoreno score
ShapeROUND (Tablet) Size11mm
FlavorImprint Code 36
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64175-991-9090 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2011
2NDC:64175-991-4545 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2011
3NDC:64175-991-25250 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/16/2011
Labeler - Foster Regal Laboratories (807396481)
Registrant - Dee Cee Laboratories (034731893)

Revised: 12/2023
Document Id: 0cc9f504-80ab-437d-e063-6294a90a6a08
Set id: ea434cd3-e4d5-44c1-a9cf-5d1a45280e90
Version: 4
Effective Time: 20231218
 
Foster Regal Laboratories