Deconex Ir Tablets

Deconex Ir Tablets
SPL v5
SPL
SPL Set ID 4710095e-3dae-4a39-8a98-873012e1f003
Route
ORAL
Published
Effective Date 2016-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (385 mg) Phenylephrine (10 mg)
Inactive Ingredients
Fd&c Yellow No. 5 Fd&c Blue No. 1 Magnesium Stearate Cellulose, Microcrystalline Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: POLY;716 Shape: oval Color: green Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-08-08

Description

Deconex IR Drug Facts

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Deconex IR Drug Facts

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

  • helps loosen phlegm and thin bronchial secretions to make coughs more productive

  • nasal congestion

  • runny nose

  • sneezing

  • itching of the nose or throat

  • itchy, watery eyes
Section 42229-5

Deconex IR

Drug Facts

Warnings

Do not exceed recommended dosage.

A persistent cough may be a sign of a serious  condition. If cough persists for more than 1 week,  tends to recur, or is accompanied by fever, rash, or  persistent headache, consult a doctor.

Ask a doctor before use if you have

  • a persistent or chronic cough such as occurs  with smoking, asthma, chronic bronchitis, or  emphysema, or if cough is accompanied by  excessive phlegm

  • heart disease

  • high blood  pressure

  • thyroid disease

  • diabetes

  • difficulty in urination due to enlargement of the  prostate gland

Ask a doctor before use if you are taking   sedatives or tranquilizers.

Directions:

Adults and children 12 years of age and older: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.

Children age 6 to 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 6 years of age and younger: Consult a physician.

Other Information

Tamper evident: do not use if tamper evident seal is broken or missing. Store at 15°-30°C (59°-86°F).

Deconex IR Tablets are a green, oval, scored tablet debossed POLY 716 on one side, plain on the other.

Active Ingredients

Guaifenesin 385 mg

Inactive Ingredients

FD&C Yellow No. 5, FD&C Blue No. 1, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Manufactured for:

Poly Pharmaceuticals

Huntsville, AL 35763

(800) 882-1041

Rev. 06/16

Principal Display Panel

NDC 50991-736-90

Deconex IR

Tablets

90 Tablets

Stop Use and Ask A Doctor If
  • nervousness, dizziness or sleeplessness occur
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.

Ask A Doctor Or Pharmacist Before Use

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.


Structured Label Content

Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

  • helps loosen phlegm and thin bronchial secretions to make coughs more productive

  • nasal congestion

  • runny nose

  • sneezing

  • itching of the nose or throat

  • itchy, watery eyes
Section 42229-5 (42229-5)

Deconex IR

Drug Facts

Purpose

Expectorant

Warnings

Do not exceed recommended dosage.

A persistent cough may be a sign of a serious  condition. If cough persists for more than 1 week,  tends to recur, or is accompanied by fever, rash, or  persistent headache, consult a doctor.

Ask a doctor before use if you have

  • a persistent or chronic cough such as occurs  with smoking, asthma, chronic bronchitis, or  emphysema, or if cough is accompanied by  excessive phlegm

  • heart disease

  • high blood  pressure

  • thyroid disease

  • diabetes

  • difficulty in urination due to enlargement of the  prostate gland

Ask a doctor before use if you are taking   sedatives or tranquilizers.

Directions:

Adults and children 12 years of age and older: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.

Children age 6 to 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 6 years of age and younger: Consult a physician.

Other Information (Other information)

Tamper evident: do not use if tamper evident seal is broken or missing. Store at 15°-30°C (59°-86°F).

Deconex IR Tablets are a green, oval, scored tablet debossed POLY 716 on one side, plain on the other.

Active Ingredients (Active ingredients)

Guaifenesin 385 mg

Inactive Ingredients (Inactive ingredients)

FD&C Yellow No. 5, FD&C Blue No. 1, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Manufactured for:

Poly Pharmaceuticals

Huntsville, AL 35763

(800) 882-1041

Rev. 06/16

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50991-736-90

Deconex IR

Tablets

90 Tablets

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness or sleeplessness occur
If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

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.


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