RYMED: Package Insert and Label Information

RYMED- dexchlorpheniramine maleate and phenylephrine hydrochloride tablet, coated
EDWARDS PHARMACEUTICALS, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients (in each tablet) 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 mellitus
  • 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.

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions or Comments?

Call 1-800-543-9560

PRINCIPAL DISPLAY PANEL — 100 Tablet Bottle Label

E
NDC 0485-0080-01
RYMED TABLETS
Antihistamine • Nasal Decongestant

Each tablet contains:
Dexchlorpheniramine Maleate 2 mg
Phenylephrine HCl 10 mg
This bottle is not to be dispensed to consumer.
Dispense in a tight, light-resistant container
with a child-resistant cap.

Store at 59°-86° (15°-30°C) [see USP Controlled Room Temperature].
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

100 tablets

Principal Display Panel -- 100 Tablet Bottle LabelPrincipal Display Panel — 100 Tablet Bottle Label
RYMED
dexchlorpheniramine maleate and phenylephrine hydrochloride tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0485-0080
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXCHLORPHENIRAMINE MALEATE (DEXCHLORPHENIRAMINE) DEXCHLORPHENIRAMINE MALEATE 2 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A CORN
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 12mm
Flavor Imprint Code R;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0485-0080-01 100 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 11/15/2011
Labeler — EDWARDS PHARMACEUTICALS, INC. (195118880)

Revised: 03/2020 EDWARDS PHARMACEUTICALS, INC.

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