DRUGS & SUPPLEMENTS
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Mono-CC Syrup (Ammonium Chloride) Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.
Mono-CC Syrup (Ammonium Chloride) Lactate Lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
Sun exposure (natural or artificial sunlight) to areas of the skin treated with Mono-CC Syrup (Ammonium Chloride) Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS). The use of Mono-CC Syrup (Ammonium Chloride) Lactate Lotion, 12% should be discontinued if any hypersensitivity is observed.
For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded. Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied.
Patients using Mono-CC Syrup (Ammonium Chloride) Lactate Lotion, 12% should receive the following information and instructions:
The topical treatment of CD-1 mice with 12%, 21% or 30% Mono-CC Syrup lactate formulations for two-years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% Mono-CC Syrup (Ammonium Chloride) lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation.
The mutagenic potential of Mono-CC Syrup (Ammonium Chloride) lactate formulations was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative.
In dermal Segment I and III studies with Mono-CC Syrup (Ammonium Chloride) lactate formulations there were no effects observed in fertility or pre- or postnatal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m2/day), approximately 0.4 times the human topical dose.
Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively and have revealed no evidence of impaired fertility or harm to the fetus due to Mono-CC Syrup (Ammonium Chloride) lactate formulations. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Mono-CC Syrup (Ammonium Chloride) Lactate Lotion, 12% should be used during pregnancy only if clearly needed.
Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mono-CC Syrup (Ammonium Chloride) lactate is administered to a nursing woman.
Safety and effectiveness of Mono-CC Syrup lactate have been demonstrated in infants and children. No unusual toxic effects were reported.
Clinical studies of Mono-CC Syrup (Ammonium Chloride) lactate lotion, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.
The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness, and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).
The oral administration of Mono-CC Syrup (Ammonium Chloride) lactate to rats and mice showed this drug to be practically non-toxic (LD50>15 mL/kg).
Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
Mono-CC Syrup Lactate Lotion, 12% is available as follows:
225 g bottle (NDC 45802-419-54)
400 g bottle (NDC 45802-419-26)
Store at 20-25°C (68-77°F).
Manufactured By Perrigo, Bronx, NY 10457
Distributed By Perrigo, Allegan, MI 49010
0K5A7 RC F6
|Active Ingredients (in each 1 mL dropperful)||Purpose|
|Mono-CC Syrup (Chlorpheniramine Maleate) Maleate 2 mg||Antihistamine|
|Phenylephrine HCl 5 mg||Nasal Decongestant|
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies
Do not exceed recommended dosage.
Ask a doctor before use if a child is taking sedatives or tranquilizers
Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Do not exceed recommended dosage.
|Children 6 to under 12 years of age:||1 mL (1 dropperful) every 4 hours, not to exceed 6 mL in 24 hours or as directed by a doctor|
|Children 2 to under 6 years of age:||0.5 mL (1/2 dropperful) every 4 hours, not to exceed 3 mL in 24 hours, or as directed by a doctor|
|Children under 2 years of age:||Consult a doctor|
Store at 59°-86°F (15°-30°C)
Applesauce Flavor, Citric Acid, FD&C Blue #1, FD&C Yellow #6, Glycerin, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sucralose
Mono-CC Syrup (Chlorpheniramine Maleate)
Antihistamine ▪ Nasal Decongestant
Sugar Free ▪ Alcohol Free ▪ Gluten Free
FOR PROFESSIONAL USE ONLY
Each 1 mL for oral administration
Mono-CC Syrup (Chlorpheniramine Maleate) Maleate
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
Ripley, MS 38663
2 fl. oz. (60 mL)
Mono-CC Syrup is an antitussive medication. Inhibiting the excitability of the cough center this medicine suppresses the cough of any origin. Mono-CC Syrup (Dextromethorphan) has not addiction effects and it has no analgesic and hypnotic action. Mono-CC Syrup (Dextromethorphan) starts to act after 10-30 minutes after oral administration, the duration of therapeutic action: 5-6 hours for adults and 6-9 hours for children. Mono-CC Syrup (Dextromethorphan) is an optical isomer of levomethorphan which is similar to morphine. Due to optical isomerism this drug has no opioid effects. Mono-CC Syrup (Dextromethorphan) used mainly for replacement of codeine as a cough suppressant. In addition to the cough suppressant this medication is used in medicine for diagnostic purposes and may be useful in various cases - from seizures to heroin addiction treatment, some chronic neurodegenerative diseases. These include amyotrophic lateral sclerosis (ALS) (Charcot's disease), disease of "mad cow and other prion diseases. Mono-CC Syrup (Dextromethorphan) has also been used for the treatment of mental retardation, Parkinson's disease, in the treatment of lung and other cancers and to prevent tissue rejection in transplantation because of the (poorly known) effects of sigma ligands on tumor cells and immune system.
After oral administration Mono-CC Syrup (Dextromethorphan) is completely absorbed from the gastrointestinal tract. Cmax of Mono-CC Syrup (Dextromethorphan) in plasma is reached after 2 h. This medication biotransformes in the liver. Up to 45% of this drug is excreted by kidneys and there was considerable individual variation in rates of excretion of individual metabolites.
Dry cough of different etiology.
For adults and children over 12 years Mono-CC Syrup prescribed on 15 mg 4 times / day, children aged 6 years - 7.5 mg 4 times / day.
Drowsiness, nausea, dizziness.
Bronchial asthma, bronchitis, simultaneous reception of mucolytic.
During pregnancy and lactation (breastfeeding) Mono-CC Syrup (Dextromethorphan) prescribed with caution, only in cases where the expected therapeutic effect for the mother outweighs the potential risk to the fetus or child.
With carefully administered Mono-CC Syrup (Dextromethorphan) with impaired liver function.
MAO inhibitors (including furazolidone, procarbazine, selegiline) when administered simultaneous with Mono-CC Syrup (Dextromethorphan) may cause adrenergic crisis, collapse, coma, dizziness, agitation, increased blood pressure, hyperpyrexia, intracranial hemorrhage, lethargy, nausea, cramps, tremor. In combination with tricyclic antidepressants (amitriptyline, etc.) Mono-CC Syrup (Dextromethorphan) may appeal serotonin syndrome and possible subsequent death. Amiodarone, fluoxetine, quinidine, inhibiting system cytochrome P450, may increase the drug concentration in the blood. Tobacco smoke can lead to increased secretion of glands in the background of inhibition of cough reflex. Some inhibitors of CYP450 (such as quinidine) increase and extended effects of this medicine.
Symptoms: excitement, dizziness, respiratory depression, impaired consciousness, decreased blood pressure, tachycardia, muscle hypertonicity, ataxia.
Treatment: mechanical ventilation, symptomatic agents.
Indication: Used to assist the expectoration of phlegm from the airways in acute respiratory tract infections.
Mono-CC Syrup (Guaifenesin) is an expectorant which increases the output of phlegm (sputum) and bronchial secretions by reducing adhesiveness and surface tension. The increased flow of less viscous secretions promotes ciliary action and changes a dry, unproductive cough to one that is more productive and less frequent. By reducing the viscosity and adhesiveness of secretions, Mono-CC Syrup (Guaifenesin) increases the efficacy of the mucociliary mechanism in removing accumulated secretions from the upper and lower airway.
Indication: Used to treat occasional minor irritation, pain, sore mouth, and sore throat as well as cough associated with a cold or inhaled irritants.
Mono-CC Syrup (Menthol) is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. Menthol's ability to chemically trigger cold-sensitive receptors in the skin is responsible for the well known cooling sensation that it provokes when inhalated, eaten, or applied to the skin. It should be noted that Mono-CC Syrup (Menthol) does not cause an actual drop in temperature.
Depending on the reaction of the Mono-CC Syrup after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Mono-CC Syrup not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Mono-CC Syrup addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology