Rymed Tablets

Rymed Tablets
SPL v5
SPL
SPL Set ID c1d6e914-74cc-4cdf-9587-7eaaa4a386e5
Route
ORAL
Published
Effective Date 2013-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dexchlorpheniramine (2 mg) Phenylephrine (10 mg)
Inactive Ingredients
Magnesium Stearate Cellulose, Microcrystalline Sodium Starch Glycolate Type A Corn

Identifiers & Packaging

Pill Appearance
Imprint: R;1 Shape: oval Color: white Size: 12 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-11-15

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Section 50570-1
  • 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.
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active Ingredients

(in each tablet)
Purpose
Dexchlorpheniramine Maleate 2 mg Antihistamine
Phenylephrine HCl 10 mg Nasal Decongestant
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

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
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
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


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Section 50570-1 (50570-1)
  • 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.
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active Ingredients

(in each tablet)
Purpose
Dexchlorpheniramine Maleate 2 mg Antihistamine
Phenylephrine HCl 10 mg Nasal Decongestant
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 (Inactive ingredients)

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions Or Comments? (Questions or Comments?)

Call 1-800-543-9560

When Using This Product (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 (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
Ask A Doctor Before Use If You Have (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
Principal Display Panel 100 Tablet Bottle Label (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


Advanced Ingredient Data


Raw Label Data

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