Guaifenesin 200mg

Guaifenesin 200mg
SPL v2
SPL
SPL Set ID 45ac210a-8c54-4469-8e10-e6fe52b89cb5
Route
ORAL
Published
Effective Date 2020-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg)
Inactive Ingredients
Silicon Dioxide Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Povidone Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: G2 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-01

Description

GUAIFENESIN 200 MG TABLETS Marlex Pharmaceuticals, Inc. ---------- Drug Fact

Purpose

Expectorant Guaifenesin 200 mg Tablets


Medication Information

Purpose

Expectorant

Guaifenesin 200 mg Tablets

Description

GUAIFENESIN 200 MG TABLETS Marlex Pharmaceuticals, Inc. ---------- Drug Fact

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive

Section 42229-5

GUAIFENESIN 200 MG TABLETS

Marlex Pharmaceuticals, Inc.

----------

Drug Fact

Warnings

Ask a doctor before use if you have

  • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • Cough accompanied by too much phlegm (mucus)
Directions:
  • Do not take more than 6 doses in any 24-hour period.

  • This product is not intended for use in children under 12 years of age

  • Adults & children 12 years and over: 1 to 2 tablets every 4 hours

  • Children under 12 years: do not use
Other Information:
  • Store at 15°C-30°C (59°F-86°F)
Inactive Ingredients:

Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 02/19TCL

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 200 mg
3000 71610-434-18

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20200619JH

Stop Use and Ask A Doctor If

cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. 

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

 

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding

ask a health professional before use.

Principal Display Panel 200 Mg

NDC 71610-434 - Guaifenesin 200 mg Tablets

Active Ingredient (in Each Tablet)

Guaifenesin 200mg


Structured Label Content

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive

Section 42229-5 (42229-5)

GUAIFENESIN 200 MG TABLETS

Marlex Pharmaceuticals, Inc.

----------

Drug Fact

Purpose

Expectorant

Guaifenesin 200 mg Tablets

Warnings

Ask a doctor before use if you have

  • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • Cough accompanied by too much phlegm (mucus)
Directions:
  • Do not take more than 6 doses in any 24-hour period.

  • This product is not intended for use in children under 12 years of age

  • Adults & children 12 years and over: 1 to 2 tablets every 4 hours

  • Children under 12 years: do not use
Other Information:
  • Store at 15°C-30°C (59°F-86°F)
Inactive Ingredients:

Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 02/19TCL

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 200 mg
3000 71610-434-18

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20200619JH

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. 

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

 

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.

If Pregnant Or Breast Feeding (If pregnant or breast- feeding)

ask a health professional before use.

Principal Display Panel 200 Mg (PRINCIPAL DISPLAY PANEL - 200 mg)

NDC 71610-434 - Guaifenesin 200 mg Tablets

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Guaifenesin 200mg


Advanced Ingredient Data


Raw Label Data

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