Restful Legs Tablet, Soluble
FDA Label NDC 54973-3162

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 Restful Legs (NDC 54973-3162). 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 - ask doctor, otc - keep out of reach of children, otc - do not use, otc - stop 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.
Arsenicum Album 12X HPUScreeping, crawling itch
Lycopodium 6X HPUSrestless legs while lying down
Pulsatilla 6X HPUSconstant urge to move legs
Rhus Toxicodendron 6X HPUSrestless legs, better with activity
Sulphur 6X HPUSitching, tingling, and urge to move legs
Zincum Metallicum 12X HPUStwitching and jerking of legs while sitting

Uses

Temporarily relieves symptoms of the compelling urge to jerk or move legs to relieve sensations of itching, tingling, crawling, and restlessness of legs. Symptoms may occur while sitting or lying down, and improve with activity.

Otc - Ask Doctor

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.

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.

Otc - Stop Use

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 and Children 12 years and over:Dissolve 2-3 tablets under tongue every 4 hours, 6 times per day.
Children ages 6-12 years:Dissolve 1-2 tablets under tongue every 4 hours, 6 times per day.

Inactive Ingredients

Acacia Gum, Lactose N.F.

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