Other
GUAIFENESIN400MG CAPLETS
MarlexPharmaceuticals, Inc.
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Drug Fact
Guaifenesin 400mg Tablet
FDA Label NDC 10135-790
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marlex Pharmaceuticals Inc for the product Guaifenesin 400mg (NDC 10135-790). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each tablet), purpose, uses, warnings, stop use and ask a doctor if, if pregnant or breast- feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Guaifenesin 400mg
Purpose
Expectorant
Guaifenesin 400 mg Caplets
Uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive
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)
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.
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.
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
790-30 (790 30)
NDC 10135-0790-60
Guaifenesin
400 mg
60 CAPLETS
790-60 (790 60)
* Please review the disclaimer below.
