Calms Forte Tablet
FDA Label NDC 54973-3274

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hyland's Inc. for the product Calms Forte (NDC 54973-3274). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, otc - pregnancy or breast feeding, otc - ask doctor, otc - keep out of reach of children, otc - do not use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Avena Sativa 4X HPUSstress, nervousness
Calcarea Phosphorica 3X HPUSrestlessness
Chamomilla 4X HPUSnervous irritability
Ferrum Phosphoricum 3X HPUSnervousness
Humulus Lupulus 4X HPUSoccasional sleeplessness
Kali Phosphoricum 3X HPUSirritability
Magnesia Phosphorica 3X HPUSmental anxiousness
Natrum Phosphoricum 3X HPUSanxiousness
Passiflora 4X HPUSrestless sleep from exhaustion

Uses

Temporarily relieves the symptoms of occasional sleeplessness and restlessness with accompanying stress, anxiousness, nervousness and irritability.

Otc - Pregnancy Or Breast Feeding

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Otc - Ask Doctor

Consult a physician if symptoms persist for more than 7 days.

Otc - Keep Out Of Reach Of Children

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

In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Otc - Do Not Use

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 1/2 to 1 hour before retiring. Children 6-12 years: As a relaxant: swallow 1 caplet with water as needed three times daily. For occasional sleeplessness: 1-2 caplets 1/2 to 1 hour before retiring.

Inactive Ingredients

Lactose, Magnesium Stearate, Microcrystalline Cellulose, Starch (Corn and Tapioca).

Questions Or Comments?

(800) 624-9659

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