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DRUGS & SUPPLEMENTS
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What are the side effects you encounter while taking this medicine? |
Chlorpheniramine Maleate:
Drug Facts
Active Ingredients (in each 1 mL dropperful) | Purpose |
---|---|
Nefacool (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
Call 1-800-543-9560
Rev. 05/11
E
NEW
FORMULA
NDC 00485-0096-02
Nefacool (Chlorpheniramine Maleate)
Pediatric Drops
Antihistamine ▪ Nasal Decongestant
Sugar Free ▪ Alcohol Free ▪ Gluten Free
FOR PROFESSIONAL USE ONLY
Each 1 mL for oral administration
contains:
Nefacool (Chlorpheniramine Maleate) Maleate
2 mg
Phenylephrine HCl
5 mg
APPLESAUCE FLAVOR
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
Manufactured for:
EDWARDS
Pharmaceuticals, Inc.
Ripley, MS 38663
2 fl. oz. (60 mL)
Methylcellulose:
Nefacool (Methylcellulose) (a non-allergenic fiber) 500mg
Bulk-forming fiber laxative
Choking: taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.
These could be signs of a serious condition.
In case of overdose, get medical help or contact a Poison Control Center right away.
Take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
Age | Dose | Maximum Dose |
adults & children 12 years of age and over | start with 2 caplets. Increase as needed up to 6 times per day. | do not exceed 12 caplets per day |
children 6 - 11 years of age | start with 1 caplet. Increase as needed up to 6 times per day. | do not exceed 6 caplets per day |
children under 6 years of age | consult a physician | consult a physician |
crospovidone, dibasic calcium phosphate, FD&C yellow no. 6 aluminum lake, magnesium stearate, maltodextrin, povidone, sodium lauryl sulfate
call toll-free 1-800-897-6081 weekdays
TAMPER EVIDENT PACKAGE
BOTTLE SEALED WITH PRINTED FOIL UNDER CAP.
DO NOT USE IF FOIL IS MISSING OR BROKEN.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
Patent Nos. 6350469, 7125562, 6372253, 7132114.
©2012 GSK or its licensor.
*When Used As Directed.
**Based On Laboratory Testing.
Individual Results May Vary.
Among Top 5 National Brands.
Trademarks are owned by or licensed to the GSK group of
Naphazoline Hydrochloride:
Nefacool (Naphazoline Hydrochloride) OPHTHALMIC SOLUTION USP, 0.1%
Naphazoline HCl, an ocular vasoconstrictor, is an imidazoline derivative sympathomimetic amine. The active ingredient is represented by the structural formula:
Chemical Name:2-(1-naphthylmethyl)-2-imidazoline monohydrochlorideVASOCON REGULAR ophthalmic solution is a sterile solution containing 1 mg/mL Nefacool (Naphazoline Hydrochloride) in an isotonic solution containing polyethylene glycol 8000, sodium chloride, polyvinyl alcohol, edetate disodium and purified water; preserved with benzalkonium chloride. Hydrochloric acid and/or sodium hydroxide added to adjust pH. It has a pH of 5.5 to 7.0.CLINICAL PHARMACOLOGY
Naphazoline constricts the vascular system of the conjunctiva. It is presumed that this effect is due to direct stimulation action of the drug upon the alpha adrenergic receptors in the arterioles of the conjunctiva resulting in decreased conjunctival congestion. Naphalozine belongs to the imidazoline class of sympathomimetics.
INDICATIONS AND USAGE
Nefacool (Naphazoline Hydrochloride) REGULAR is indicated for use as a topical ocular vasoconstrictor.
CONTRAINDICATIONS
Contraindicated in the presence of an anatomically narrow angle or in narrow angle glaucoma or in persons who have shown hypersensitivity to any component of this preparation.
WARNINGS
Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug. Use in children, especially infants, may result in CNS depression leading to coma and marked reduction in body temperature.
PRECAUTIONSGeneral
Use with caution in the presence of hypertension, cardiovascular abnormalities, hyperglycemia (diabetes), hyperthyroidism, ocular infection or injury and when other medications are being used.
Patient Information
Patients should be advised to discontinue the drug and consult a physician if relief is not obtained within 48 hours of therapy, if irritation, blurring, or redness persists or increases, or if symptoms of systemic absorption occur, i.e., dizziness, headache, nausea, decrease in body temperature, or drowsiness.
To prevent contaminating the dropper tip and solution, do not touch the eyelids or the surrounding area with the dropper tip of the bottle. If solution changes color or becomes cloudy, do not use.Drug Interactions
Concurrent use of maprotiline or tricyclic antidepressants and naphazoline may potentiate the pressor effect of naphazoline. Patients under therapy with MAO inhibitors may experience a severe hypertensive crisis if given a sympathomimetic drug..
Pregnancy Category C
Animal reproduction studies have not been conducted with naphazoline. It is also not known whether naphazoline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Naphazoline should be given to a pregnant woman only if clearly needed.
Nursing Mothers
If is not known whether naphazoline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when naphazoline is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in children have not been established. See “WARNINGS” and “CONTRAINDICATIONS”.
ADVERSE REACTIONSOcular
Mydriasis, increased redness, irritation, discomfort, blurring, punctate keratitis, lacrimation, increased intraocular pressure.
Systemic
Dizziness, headache, nausea, sweating, nervousness drowsiness, weakness, hypertension, cardiac irregularities, and hyperglycemia.
DOSAGE AND ADMINISTRATION
Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.
HOW SUPPLIED
Nefacool (Naphazoline Hydrochloride) REGULAR (naphazoline hydrochloride ophthalmic solution USP, 0.1%): 15 mL plastic squeeze bottle with dropper tip. NDC 58768-844-15 To be dispensed only in original, unopened container. Store at controlled room temperature 15°-30°C (59°-86°F).
CAUTION: Federal law prohibits dispensing without prescription. Mfd. by OMJ Pharmaceuticals, Inc.,San Germán, P.R., 00683 for:CIBA VisionOphthalmics®___________________Atlanta, Georgia 301556072-A
Depending on the reaction of the Nefacool after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Nefacool 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 Nefacool 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