Guaifenesin 400mg

Guaifenesin 400mg
SPL v5
SPL
SPL Set ID 43ca292e-3128-47fc-9f20-b7e8c8677d4d
Route
ORAL
Published
Effective Date 2019-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Silicon Dioxide Fd&c Red No. 40 Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Povidone Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: G400 Shape: capsule Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-01

Description

GUAIFENESIN 400 MG TABLETS Marlex Pharmaceuticals, Inc. ---------- Drug Fact

Purpose

Expectorant Guaifenesin 4 00 mg Tablets


Medication Information

Purpose

Expectorant

Guaifenesin 4 00 mg Tablets

Description

GUAIFENESIN 400 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 400 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, FD&C RED #40(AI-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 02/19TCL

Principal Display Panel

NDC 10135-0682-30

Guaifenesin

400 mg

30 CAPLETS

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.

Active Ingredient (in Each Tablet)

Guaifenesin 400mg


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 400 MG TABLETS

Marlex Pharmaceuticals, Inc.

----------

Drug Fact

Purpose

Expectorant

Guaifenesin 4 00 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, FD&C RED #40(AI-lake), magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 02/19TCL

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 10135-0682-30

Guaifenesin

400 mg

30 CAPLETS

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.

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

Guaifenesin 400mg


Advanced Ingredient Data


Raw Label Data

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