Active Ingredients (In Each Tablet)
- Dexchlorpheniramine Maleate - 2 mg
- Phenylephrine HCl - 10 mg
Dexchlorpheniramine Maleate, Phenylephrine Hcl
FDA Label NDC 66576-080
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Syntho Pharmaceuticals Inc. for the product Dexchlorpheniramine Maleate, Phenylephrine Hcl (NDC 66576-080). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each tablet), inactive ingredients, purpose, uses, warnings, directions, questions or comments?, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Lactose Monohydrate, Microcrystalline Cellulose, Magnesium Stearate, Purified Water, PEG, HPMC
Purpose
- Dexchlorpheniramine Maleate 2 mg - Antihistamine
- Phenylephrine HCl 10 mg - 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 (MAOI) (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
■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes mellilus
■ difficulty in urination due to enlargement of the prostate gland
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
■ alcohol, sedatives and tranquilizers may increase the drowsiness effect
■ avoid alcoholic beverages
■ 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 a fever
■ new symptoms occur
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Directions
Do not exceed recommended dosage.
| Adults and children 12 years of age and over: | 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor |
| Children 6 to under 12 years of age: | 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor |
| Children under 6 years of age: | Consult a doctor. |
Questions Or Comments?
Call 1-800-664-1490
Package Label.Principal Display Panel
Rymed Tablets - NDC 66576-080-01 - 100's Bottle Label
Rymed Tablets (Rymed Tablets 100s Bottle Label)
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