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| Product NDC Code | 54973-4009 | ||||||||||
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| Drug Name | Pain relief |
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| Type | Brand | ||||||||||
| Pharm Class | Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | TABLET | ||||||||||
| Labeler Name | Hyland's Inc. | ||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Active ingredients Purpose Bryonia Alba 6X HPUS minor joint pain, headache, muscle cramps Hypericum Perforatum 6X HPUS backache, headache, minor joint pain Kali Phosphoricum 6X HPUS pain in neck/shoulders, headache Magnesia Phosphorica 12X HPUS muscle pain, backache Rhus Toxicodendron 6X HPUS minor joint pain, headache, neck pain "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions ■ Use as directed. Adults and children 12 years and over At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved. Children under 12 years of age Ask a doctor before use.
| Adults and children 12 years and over | At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved. |
| Children under 12 years of age | Ask a doctor before use. |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acacia Gum, Lactose.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses ■ Temporarily relieves: ■ minor joint pain ■ headache ■ muscle pain ■ backache ■ muscle cramps ■ pain in neck or shoulders
Purpose
Information about the drug product’s indications for use.Pain Relief
Spl product data elements
Usually a list of ingredients in a drug product.Pain Relief DIBASIC POTASSIUM PHOSPHATE,HYPERICUM PERFORATUM,TOXICODENDRON PUBESCENS LEAF,BRYONIA ALBA ROOT and MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE LACTOSE MONOHYDRATE ACACIA MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE MAGNESIUM CATION TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF DIBASIC POTASSIUM PHOSPHATE POTASSIUM CATION BRYONIA ALBA ROOT BRYONIA ALBA ROOT HYPERICUM PERFORATUM HYPERICUM PERFORATUM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel 54973-4009-01 100 Tablets carton 100 Tab label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Indications and Usage (Uses) Update "Temporarily relieves symptoms of pain, including:" to "Temporarily relieves:" Removed extra bullets
Dosage and Administration (Directions) ■ Use as directed Adults and children 12 years and over At onset of symptoms, dissolve 2 tablets under tongue every 15 minutes up to 4 doses. If symptoms persist, 2 tablets every 4 hours until relieved. Children under 12 years of age Ask a doctor before use.
| Adults and children 12 years and over | |
| Children under 12 years of age | Ask a doctor before use. |
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts Active ingredients Active ingredients Purpose Bryonia Alba 6X HPUS minor joint pain, headache, muscle cramps Hypericum Perforatum 6X HPUS backache, headache, minor joint pain Kali Phosphoricum 6X HPUS pain in neck/shoulders, headache Magnesia Phosphorica 12X HPUS muscle pain, backache Rhus Toxicodendron 6X HPUS minor joint pain, headache, neck pain "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? www.hylands.com or [email protected]
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if ■ pain gets worse or lasts more than 7 days. ■ new symptoms occur. ■ redness or swelling is present.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding Ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Stop use and ask a doctor if ■ pain gets worse or lasts more than 7 days. ■ new symptoms occur. ■ redness or swelling is present. If pregnant or breastfeeding Ask a health professional before use. Keep out of reach of children.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API