Guaifenesin 400mg

Guaifenesin 400mg
SPL v2
SPL
SPL Set ID 13f4db4e-687e-9d7b-e063-6294a90ab088
Route
ORAL
Published
Effective Date 2024-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Silicon Dioxide Maltodextrin Povidone Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: C16 Shape: capsule Color: white Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-01

Description

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

Purpose

Expectorant Guaifenesin 4 00 mg Caplets


Medication Information

Purpose

Expectorant

Guaifenesin 4 00 mg Caplets

Description

GUAIFENESIN 400 MG CAPLETS 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 CAPLETS

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:

Maltodextrin, Povidone, Silicon Dioxide, Stearic acid.

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 03/24 AA

Principal Display Panel

NDC 10135-0790-30

Guaifenesin

400 mg

30 CAPLETS

Stop Use and Ask A Doctor If

cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These 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 CAPLETS

Marlex Pharmaceuticals, Inc.

----------

Drug Fact

Purpose

Expectorant

Guaifenesin 4 00 mg Caplets

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:

Maltodextrin, Povidone, Silicon Dioxide, Stearic acid.

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 03/24 AA

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 10135-0790-30

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, comes back or is accompanied by fever, rash, or persistent headache. These 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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