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DRUGS & SUPPLEMENTS
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Phenylephrine Hydrochloride:
Active ingredients
(in each tablet)
Dexbrompheniramine Maleate 2 mg
Tropicamet Plus (Phenylephrine Hydrochloride) Hydrochloride 10 mg
Antihistamine
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 or pharmacist before use if you are taking sedatives or tranquilizers.
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
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 |
Store at 15° - 30°C (59° - 86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Tropicamet Plus (Phenylephrine Hydrochloride) Tablets are dark purple, caplet-shaped, scored tablets, debossed "Poly" bisect "782" on one side and plain on the other.
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.
Call1-800-882-1041
Manufactured for:
Poly Pharmaceuticals
Quitman, MS 39355 Rev. 02/12
The packaging below represents the labeling currently used.
Principal display panel and side panel for 60 tablets label:
NDC 50991-782-60
Tropicamet Plus (Phenylephrine Hydrochloride)
Tablets
Antihistamine - Nasal Decongestant
Each tablet contains:
Dexbrompheniramine Maleate...2 mg
Tropicamet Plus (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
Tropicamet Plus (Phenylephrine Hydrochloride) Tablets Packaging Tropicamet Plus (Phenylephrine Hydrochloride) Tablets Packaging
Tropicamide:
For mydriasis and cycloplegia for diagnostic procedures.
Contraindicated in persons showing hypersensitivity to any component of this preparation.
FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION
This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reaction and behavioral disturbance due to hypersensitivity to anticholinergic drugs should be considered.
Mydriatics may produce a transient elevation of intraocular pressure.
Remove contact lenses before using.
The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption.
Do not touch dropper tip to any surface, as this may contaminate the solution. Patients should be advised not to drive or engage in potentially hazardous activities while pupils are dilated. Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and wash their own hands and the child's hands following administration.
Tropicamet Plus may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
There have been no long-term studies done using Tropicamet Plus (Tropicamide) in animals to evaluate carcinogenic potential.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tropicamet Plus is administered to a nursing woman.
Tropicamet Plus (Tropicamide) may rarely cause CNS disturbances which may be dangerous in pediatric patients. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs. Keep this and all medications out of the reach of children.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Ocular
Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of Tropicamet Plus (Tropicamide). Increased intraocular pressure has been reported following the use of mydriatics.
Non-Ocular
Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of Tropicamet Plus (Tropicamide). Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For refraction, one or two drops of the 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. For examination of fundus, one or two drops of the 0.5% solution 15 or 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses. Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours. However, in some cases, complete recovery may take up to 24 hours.
Tropicamet Plus (Tropicamide) Ophthalmic Solution, USP 1% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following sizes:
2 mL - NDC 24208-585-59
15 mL - NDC 24208-585-64
Tropicamet Plus (Tropicamide) Ophthalmic Solution, USP 0.5% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following size:
15 mL - NDC 24208-590-64
Storage: Store at 20° to 25C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)
.
Keep container tightly closed.
DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW IS NOT INTACT.
KEEP OUT OF REACH OF CHILDREN.
Revised: July 2016
Bausch + Lomb, a division of
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
©Bausch & Lomb Incorporated
9115805 (folded)
9115905 (flat)
symbol
NDC 24208-590-64
Tropicamet Plus (Tropicamide)
Ophthalmic
Solution, USP
0.5% (Sterile)
FOR TOPICAL
OPHTHALMIC
USE ONLY
Rx only
15 mL
BAUSCH + LOMB
Carton5mexico.jpg
NDC 24208-590-64
Tropicamet Plus (Tropicamide)
Ophthalmic
Solution, USP
0.5% (Sterile)
FOR TOPICAL
OPHTHALMIC
USE ONLY
Rx only
15 mL
BAUSCH + LOMB
Carton5japan.jpg
NDC 24208-585-64
Tropicamet Plus (Tropicamide)
Ophthalmic
Solution, USP
1% (Sterile)
FOR TOPICAL
OPHTHALMIC
USE ONLY
Rx only
15 mL
BAUSCH + LOMB
Carton1mexico.jpg
NDC 24208-585-64
Tropicamet Plus (Tropicamide)
Ophthalmic
Solution, USP
1% (Sterile)
FOR TOPICAL
OPHTHALMIC
USE ONLY
Rx only
15 mL
BAUSCH + LOMB
Carton1japan.jpg
Depending on the reaction of the Tropicamet Plus after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Tropicamet Plus 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 Tropicamet Plus 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