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

Purpose

Expectorant

Description

Deconex IR Drug Facts


Medication Information

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.

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
Purpose

Expectorant

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.

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

Description

Deconex IR Drug Facts

Principal Display Panel

NDC 50991-736-90

Deconex IR

Tablets

90 Tablets

Section 42229-5

Deconex IR

Drug Facts

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.

Active Ingredients

Guaifenesin 385 mg

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

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.

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
Purpose

Expectorant

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.

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

Section 42229-5 (42229-5)

Deconex IR

Drug Facts

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.

Active Ingredients (Active ingredients)

Guaifenesin 385 mg

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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Raw Label Data

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