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DRUGS & SUPPLEMENTS
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Ventirex-C
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Ventirex-C uses
Ventirex-C consists of Ambroxol, Ammonium Chloride, Cetirizine Hydrochloride, Guaifenesin, Menthol, Phenylephrine Hydrochloride.Ammonium Chloride:
- Indications and usage
- Contraindications
- Warning
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
INDICATIONS AND USAGE
Ventirex-C (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.
CONTRAINDICATIONS
Ventirex-C (Ammonium Chloride) Lactate Lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
WARNING
Sun exposure (natural or artificial sunlight) to areas of the skin treated with Ventirex-C (Ammonium Chloride) Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS). The use of Ventirex-C (Ammonium Chloride) Lactate Lotion, 12% should be discontinued if any hypersensitivity is observed.
PRECAUTIONS
General -
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.
Information for Patients
Patients using Ventirex-C (Ammonium Chloride) Lactate Lotion, 12% should receive the following information and instructions:
- This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with eyes, lips, or mucous membranes.
- Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin.
- This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).
- If the skin condition worsens with treatment, the medication should be promptly discontinued.
Carcinogenesis, Mutagenesis, Impairment of Fertility -
The topical treatment of CD-1 mice with 12%, 21% or 30% Ventirex-C 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% Ventirex-C (Ammonium Chloride) lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation.
The mutagenic potential of Ventirex-C (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 Ventirex-C (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.
Pregnancy:
Teratogenic effects:
Pregnancy Category B -
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 Ventirex-C (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, Ventirex-C (Ammonium Chloride) Lactate Lotion, 12% should be used during pregnancy only if clearly needed.
Nursing Mothers -
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 Ventirex-C (Ammonium Chloride) lactate is administered to a nursing woman.
Pediatric Use -
Safety and effectiveness of Ventirex-C lactate have been demonstrated in infants and children. No unusual toxic effects were reported.
Geriatric Use -
Clinical studies of Ventirex-C (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.
ADVERSE REACTIONS
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).
OVERDOSAGE
The oral administration of Ventirex-C (Ammonium Chloride) lactate to rats and mice showed this drug to be practically non-toxic (LD50>15 mL/kg).
DOSAGE AND ADMINISTRATION
Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
HOW SUPPLIED
Ventirex-C Lactate Lotion, 12% is available as follows:
225 g bottle (NDC 45802-419-54)
400 g bottle (NDC 45802-419-26)
STORAGE
Store at 20-25°C (68-77°F).
Manufactured By Perrigo, Bronx, NY 10457
Distributed By Perrigo, Allegan, MI 49010
0K5A7 RC F6
Rev 01-17
Cetirizine Hydrochloride:
- Active ingredients (in each extended release tablet)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Questions?
Drug Facts
Active ingredients
Ventirex-C (Cetirizine Hydrochloride) HCl 5 mg
Pseudoephedrine HCl 120 mg
Purpose
Antihistamine
Nasal decongestant
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- nasal congestion
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily restores freer breathing through the nose
Warnings
Do not use
- if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
- if you are now taking a prescription monoamine oxidase inhibitor (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease
- thyroid disease
- diabetes
- glaucoma
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- liver or kidney disease. Your doctor should determine if you need a different dose.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
When using this product
- do not use more than directed
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- an allergic reaction to this product occurs. Seek medical help right away.
- you get nervous, dizzy, or sleepless
- symptoms do not improve within 7 days or are accompanied by fever
If pregnant or breast-feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
- do not break or chew tablet; swallow tablet whole
| adults and children 12 years and over | take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. |
| adults 65 years and over | ask a doctor |
| children under 12 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other information
- store between 20° to 25°C (68° to 77°F)
- do not use if individual blister unit is open or torn
- see back panel for lot number and expiration date
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
Questions?
call 1-800-343-7805
Guaifenesin:
An expectorant that also has some muscle relaxing action. It is used in many cough preparations.
Indication: Used to assist the expectoration of phlegm from the airways in acute respiratory tract infections.
Ventirex-C (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, Ventirex-C (Guaifenesin) increases the efficacy of the mucociliary mechanism in removing accumulated secretions from the upper and lower airway.
Menthol:
Ventirex-C (Menthol) is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. It is a waxy, crystalline substance, clear or white in color, which is solid at room temperature and melts slightly above. The main form of Ventirex-C (Menthol) occurring in nature is (-)-menthol, which is assigned the (1R,2S,5R) configuration. Ventirex-C (Menthol) has local anesthetic and counterirritant qualities, and it is widely used to relieve minor throat irritation.
Indication: Used to treat occasional minor irritation, pain, sore mouth, and sore throat as well as cough associated with a cold or inhaled irritants.
Ventirex-C (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 Ventirex-C (Menthol) does not cause an actual drop in temperature.
Phenylephrine Hydrochloride:
- Drug facts
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Questions? comments?
- Product packaging
Drug Facts
Active ingredients
(in each tablet)
Dexbrompheniramine Maleate 2 mg
Ventirex-C (Phenylephrine Hydrochloride) Hydrochloride 10 mg
Purpose
Antihistamine
Nasal Decongestant
Uses
Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- nasal congestion
- reduces swelling of nasal passages
Warnings
Do not exceed recommended dosage.
Do not use this product
- if you are now taking a prescription monoamine oxidase inhibitor (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to enlargement of the prostate gland
- heart disease
- high blood pressure
- thyroid disease
- diabetes
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When using this product
- excitability may occur, especially in children
- may cause drowsiness
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or are accompanied by fever
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
| Adults and children 12 years of age and over: | 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours |
| Children 6 to under 12 years of age: | 1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours |
| Children under 6 years of age: | Consult a doctor |
Other information
Store at 15° - 30°C (59° - 86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Ventirex-C (Phenylephrine Hydrochloride) Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" on one side and plain on the other.
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 aluminum lake, dibasic calcium phosphate dihydrate, FD &C Blue #1 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose.
Questions? Comments?
Call1-800-882-1041
Manufactured for:
Poly Pharmaceuticals
Quitman, MS 39355 Rev. 02/12
Product Packaging
The packaging below represents the labeling currently used.
Principal display panel and side panel for 60 tablets label:
NDC 50991-782-60
Ventirex-C (Phenylephrine Hydrochloride)
Tablets
Antihistamine - Nasal Decongestant
Each tablet contains:
Dexbrompheniramine Maleate...2 mg
Ventirex-C (Phenylephrine Hydrochloride) Hydrochloride...10 mg
60 Tablets
Usual
Dosage: See product foldout for full prescribing information.
Tamper evident by foil seal under cap. Do not use if foil seal is
broken or missing.
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.
Store at controlled room temperature between 15°-30°C (59°-86°F).
Manufactured for:
Poly Pharmaceuticals
Quitman, MS 39355
Rev. 02/12
Ventirex-C (Phenylephrine Hydrochloride) Tablets Packaging Ventirex-C (Phenylephrine Hydrochloride) Tablets Packaging
Ventirex-C pharmaceutical active ingredients containing related brand and generic drugs:
Ventirex-C available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.