Mydrin-P

Phenylephrine Hydrochloride:

• Drug facts
• Purpose
• Uses
• Warnings
• Directions
• Other information
• Inactive ingredients
• Questions? comments?
• Product packaging
• Mydrin-P (Phenylephrine Hydrochloride) reviews

Drug Facts

Active ingredients

(in each tablet)

Dexbrompheniramine Maleate 2 mg

Mydrin-P (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

Other information

Store at 15° - 30°C (59° - 86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Mydrin-P (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

Mydrin-P (Phenylephrine Hydrochloride)

Tablets

Antihistamine - Nasal Decongestant

Each tablet contains:

Dexbrompheniramine Maleate...2 mg

Mydrin-P (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

Mydrin-P (Phenylephrine Hydrochloride) Tablets Packaging Mydrin-P (Phenylephrine Hydrochloride) Tablets Packaging

Tropicamide:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Dosage and administration
• How supplied
• Mydrin-P (Tropicamide) reviews

INDICATIONS AND USAGE

For mydriasis and cycloplegia for diagnostic procedures.

CONTRAINDICATIONS

Contraindicated in persons showing hypersensitivity to any component of this preparation.

WARNINGS

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.

PRECAUTIONS

Pregnancy Category C. Animal reproduction studies have not been conducted with Mydrin-P. It is also not known whether Mydrin-P (Tropicamide) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Mydrin-P (Tropicamide) should be given to a pregnant woman only if clearly needed.

General

The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption.

Information for Patients

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.

Drug Interactions

Mydrin-P may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no long-term studies done using Mydrin-P (Tropicamide) in animals to evaluate carcinogenic potential.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Mydrin-P. It is also not known whether Mydrin-P (Tropicamide) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Mydrin-P (Tropicamide) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

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 Mydrin-P is administered to a nursing woman.

Pediatric Use

Mydrin-P (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.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS

Ocular

Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of Mydrin-P (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 Mydrin-P (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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Mydrin-P (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

Mydrin-P (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

Mydrin-P (Tropicamide)

Ophthalmic

Solution, USP

0.5% (Sterile)

FOR TOPICAL

OPHTHALMIC

USE ONLY

Rx only

15 mL

BAUSCH + LOMB

Carton5mexico.jpg

NDC 24208-590-64

Mydrin-P (Tropicamide)

Ophthalmic

Solution, USP

0.5% (Sterile)

FOR TOPICAL

OPHTHALMIC

USE ONLY

Rx only

15 mL

BAUSCH + LOMB

Carton5japan.jpg

NDC 24208-585-64

Mydrin-P (Tropicamide)

Ophthalmic

Solution, USP

1% (Sterile)

FOR TOPICAL

OPHTHALMIC

USE ONLY

Rx only

15 mL

BAUSCH + LOMB

Carton1mexico.jpg

NDC 24208-585-64

Mydrin-P (Tropicamide)

Ophthalmic

Solution, USP

1% (Sterile)

FOR TOPICAL

OPHTHALMIC

USE ONLY

Rx only

15 mL

BAUSCH + LOMB

Carton1japan.jpg