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| Product NDC Code | 61480-310 | ||||||||||||||
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| Drug Name | Dandruff |
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| Type | Brand | ||||||||||||||
| Pharm Class | Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||||
| Dosage Form | TABLET | ||||||||||||||
| Labeler Name | PLYMOUTH HEALTHCARE PRODUCTS LLC | ||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS / PURPOSE Active ingredients (HPUS*) in each 750mg Pill Purpose** Kali Bromatum 1X HPUS Itching, Scaling & Redness Kali Muriaticum 1X HPUS Dry, White Scales Kali Sulphuricum 1X HPUS Flaking Natrum Muriaticum 1X HPUS Oily Scalp, Itchy, Burning Scalp Sulphur 1X HPUS Dry, Scaly, Itchy Skin & Scalp Calcarea Carbonica 3X HPUS White, Crusty Scales Niccolum Sulphuricum 3X HPUS Skin Itching
| Kali Bromatum 1X HPUS | Itching, Scaling & Redness |
| Kali Muriaticum 1X HPUS | Dry, White Scales |
| Kali Sulphuricum 1X HPUS | Flaking |
| Natrum Muriaticum 1X HPUS | Oily Scalp, Itchy, Burning Scalp |
| Sulphur 1X HPUS | Dry, Scaly, Itchy Skin & Scalp |
| Calcarea Carbonica 3X HPUS | White, Crusty Scales |
| Niccolum Sulphuricum 3X HPUS | Skin Itching |
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 Directions: Adults & Children 50 lbs & Up: Take ONCE per day as indicated on the chart below according to your weight: Weight Daily Dosage 50 - 100 lbs ...................... (2) Pills Daily 100 - 150 lbs .................... (4) Pills Daily 150 - 200 lbs .................... (6) Pills Daily 200 - 250 lbs .................... (8) Pills Daily Over 250 lbs ..................... (10) Pills Daily Swallow whole. For optimal absorption, take orally at bedtime or in the morning - on an empty stomach. Do not eat or drink anything but water for 1 hour after taking.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients : Fumaric Acid, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Natural Blueberry Flavor, Organic Spirulina Powder, Sucrose.
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 Uses: For the temporary relief of Dandruff symptoms.** The claims for this product are based upon traditional homeopathic practice. They have not been reviewed by the FDA.
Purpose
Information about the drug product’s indications for use.Relieves Symptoms of Dandruff: Itchy Scalp Dryness/Irritation Flaking Oily Scalp Promotes Scalp Health
Spl product data elements
Usually a list of ingredients in a drug product.DANDRUFF Kali Bromatum, Kali Muriaticum, Kali Sulphuricum, Natrum Muriaticum, Sulphur, Calcarea Carbonica, Niccolum Sulphuricum. FUMARIC ACID MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE BLUEBERRY SPIRULINA PLATENSIS SUCROSE POTASSIUM BROMIDE BROMIDE ION POTASSIUM CHLORIDE POTASSIUM CATION POTASSIUM SULFATE SULFATE ION SODIUM CHLORIDE CHLORIDE ION SULFUR SULFUR OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE NICKEL SULFATE HEXAHYDRATE NICKEL CATION off-white with speckles LL
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.NDC# 61480-310-01 LOMALUX LABORATORIES DANDRUFF PILL ™ HEALTHY SCALP FROM WITHIN™ Relieves Symptoms of Dandruff: Itchy Scalp Dryness/Irritation Flaking Oily Scalp Promotes Scalp Health HOMEOPATHIC ORAL MEDICATION DERMATOLOGIST DEVELOPED 1 DAILY DOSE 144 PILLS carton label bottle label Relieves Symptoms of Dandruff: Itchy Scalp Dryness/Irritation Flaking Oily Scalp Promotes Scalp Health
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.OTHER INFORMATION Other information: TAMPER EVIDENT - for your protection, this bottle has an imprinted seal around the neck. DO NOT USE if imprinted tamper evident seal band is broken or missing.
WE TARGET DANDRUFF AT ITS SOURCE - FOR HEALTHY SCALP FROM WITHIN Dandruff Pill works from the inside out to provide scalp relief from within. Just like your daily vitamin, Dandruff Pill is taken orally. With just one daily dose, Dandruff Pill's active mineral ingredients help relieve Dandruff symptoms. NATURE CREATED - DERMATOLOGIST PERFECTED We use only the finest quality ingredients in our exclusive formulation developed by our dermatologist founder to promote scalp health from within. A perfect blend of science and nature. MADE IN THE USA NATURAL active ingredients LACTOSE FREE VEGAN GLUTEN FREE EXCLUSIVE MINERAL TECHNOLOGY PROMOTES SCALP HEALTH 7 Active Mineral Ingredients help relieve dandruff symptoms of flaking, itchy scalp, dryness, and irritation. These unique inorganic minerals are all natural, earth derived. WHEN USED REGULARLY, MAY HELP RELIEVE SYMPTOMS OF DANDRUFF DERMATOLOGISTS DEVELOPED, FOR HEALTHY SKIN FROM WITHIN UNIQUE! - CUSTOMED DOSAGE ACCORDING TO YOUR WEIGHT FOR OPTIMAL RESULTS A 12 WEEK USE COURSE IS RECOMMENDED. CONTINUE TAKING AS LONG AS BENEFICIAL.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS or COMMENTS? Questions or Comments? Call 800-316-9636, Monday through Friday, 9am-5pm EST or visit www.lomalux.com Distributed by Loma Lux Laboratories: 6521 Davis Industrial Parkway, Solon, OH 44139 USA
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 Warnings: DO NOT USE if you have kidney disease in children under 12 years old children under 50 lbs if pregnant Ask a doctor before use if you have a known sensitivity to nickel or costume jewelry a known sensitivity to any ingredients in this product Stop use and ask a doctor if skin rash appears feelings of nervousness occur if condition worsens or does not improve after regular use of this product If pregnant, do not use. If breast-feeding, ask a doctor before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.
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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