berkley and jensen mucus relief
berkley and jensen mucus relief is an FDA drug label for the active ingredient GUAIFENESIN manufactured by BJWC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20220419.
- Generic name
- GUAIFENESIN
- Manufacturer
- BJWC
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 68391-000
- Application
- ANDA213420
- Label effective
- 20220419
About this product
berkley and jensen mucus relief is an FDA-registered drug product whose active ingredient is GUAIFENESIN. It is labelled by BJWC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 68391-000, application ANDA213420, label effective 20220419. It is one of 98 FDA drug label records sharing the active ingredient GUAIFENESIN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing GUAIFENESIN are most often described in connection with: helps loosen, phlegm mucus, thin bronchial, secretions rid, passageways bothersome, make coughs. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage & Administration
Directions • do not crush, chew, or break tablet • take with a full glass of water • this product can be administered without regard for the timing of meals • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. • children under 12 years of age: do not use
Warnings
Warnings Do not use • for children under 12 years of age 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 lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. hese could be signs of a serious illness. 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 (1-800-222-1222).
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View labelHow products containing GUAIFENESIN compare
FDA lists 98 drug label records with GUAIFENESIN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Bryant Ranch Prepack | 4 |
| — | — | Strategic Sourcing Services LLC | 4 |
| — | — | CVS Pharmacy | 3 |
| — | — | Cardinal Health 107, LLC | 3 |
| — | — | Reckitt Benckiser LLC | 3 |
Frequently asked questions
What is berkley and jensen mucus relief used for?
Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Who makes berkley and jensen mucus relief?
BJWC is the labeler of record for berkley and jensen mucus relief. 98 FDA label records share the active ingredient GUAIFENESIN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does berkley and jensen mucus relief come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is berkley and jensen mucus relief prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Are there other products containing GUAIFENESIN?
Yes. 98 FDA drug label records list GUAIFENESIN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has berkley and jensen mucus relief been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.