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CALMS FORTE

Hyland's

CALMS FORTE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
    Calc. Phos. HPUS 3X, Ferrum Phos. HPUS 3X, Kali Phos. HPUS 3X,
    Mag. Phos. HPUS 3X, Nat. Phos. HPUS 3X
Avena Sativa HPUS 1X Double Strength stress, nervousness
Chamomilla HPUS 2X nervous irritability
Humulus Lupulus HPUS 1X Double Strength occasional sleeplessness
Passiflora HPUS 1X Triple Strength restless sleep from exhaustion
Biochemic Phosphates enhances cellular function

CALMS FORTE Uses

Temporarily relieves the symptoms of simple nervous tension, restless sleep, and occasional sleeplessness.

Warnings

As with any drug, ask a doctor before use if pregnant or nursing.

Consult a physician if:

  • Symptoms persist for more than 7 days or worsen

Keep this and all medications out of the reach of children.

In case of accidental overdose, contact a medical professional or a poison control center immediately.

Do not use if imprinted tamper band is broken or missing.

In case of emergency, contact a medical professional or poison control center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

Adults & children 12 years and over

As a relaxant: Swallow 1-2 caplets with water as needed three times daily.

For occasional sleeplessness: 1-3 caplets ½ to 1 hour before retiring.

Children 6 to under 12 years

As a relaxant: Swallow 1 caplet with water as needed three times daily.

For occasional sleeplessness: 1-2 caplets ½ to 1 hour before retiring.

Inactive ingredients

Lactose N.F., Starch (Corn and Tapioca), Vegetable Magnesium Stearate.

PRINCIPAL DISPLAY PANEL - 32 Tablet Bottle Carton

SINCE 1903
Hyland's ®

Non-Habit Forming

CALMS FORTÉ ®
SLEEP AID

32
Caplets

MADE IN USA

CALMS FORTE

CALMS FORTE

AVENA SATIVA FLOWERING TOP, CHAMOMILE, HUMULUS LUPULUS STEM, PASSIFLORA INCARNATA FLOWER, CALCIUM PHOSPHATE, FERROSOFERRIC PHOSPHATE, POTASSIUM PHOSPHATE, DIBASIC, SODIUM PHOSPHATE, and MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54973-3113
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVENA SATIVA FLOWERING TOP AVENA SATIVA FLOWERING TOP 1 [hp_X]
CHAMOMILE CHAMOMILE 2 [hp_X]
HUMULUS LUPULUS STEM HUMULUS LUPULUS STEM 1 [hp_X]
PASSIFLORA INCARNATA FLOWER PASSIFLORA INCARNATA FLOWER 1 [hp_X]
CALCIUM PHOSPHATE CALCIUM CATION 3 [hp_X]
FERROSOFERRIC PHOSPHATE Ferrosoferric Phosphate 3 [hp_X]
potassium phosphate, dibasic PHOSPHATE ION 3 [hp_X]
sodium phosphate 3 [hp_X]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE MAGNESIUM CATION 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
LACTOSE
STARCH, CORN
STARCH, TAPIOCA
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
BROWN (BEIGE) 9 mm HYL;CF OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 32 in 1 BOTTLE, PLASTIC
2 NDC:54973-3113-2 4 in 1 POUCH
3 NDC:54973-3113-3 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
1960-10-01


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Be sure to consult your doctor before taking any medication!
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