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  5. Label Information: Relax Am-pm

FDA Label for Relax Am-pm

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Relax Am-pm Product Label

The following document was submitted to the FDA by the labeler of this product Foster Regal Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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

Otc - Purpose



For Relief of Muscle SpasmsTension and Stress

Otc - 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


Package Label.Principal Display Panel



Image of Label - relax90

Image of Label - relax90


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