Guaifenesin 600 mg/1
Guaifenesin · TABLET · Walgreens
Guaifenesin is a tablet containing guaifenesin at 600 mg/1, taken oral. Manufactured by Walgreens.
Key Facts
- Brand Name
- Guaifenesin
- Generic Name
- Guaifenesin
- NDC Code (Product)
0363-9569- Manufacturer
- Walgreens
- Strength
- 600 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA213420
- Drug Class
- Expectorant [EPC]
- Marketing Start
- 07/19/2024
Recall History
Aaron Industries Inc
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Aaron Industries Inc
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Global Corporation
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Aidapak Services, LLC
Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: AD21965_13, EXP: 5/1/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD56917_7, EXP: 5/21/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD73627_17, EXP: 5/30/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W003216
Reckitt Benckiser LLC
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Perrigo Company PLC
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Superpotent; sodium benzoate preservative
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Failed Impurity/Degradation Specifications
Ultra Seal Corporation
cGMP deviations
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 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
Frequently Asked Questions
What is Guaifenesin used for?
Guaifenesin contains Guaifenesin. It is a tablet taken oral. Consult your doctor for specific uses.
Is Guaifenesin a controlled substance?
Guaifenesin is not classified as a controlled substance by the DEA.
What is the generic name for Guaifenesin?
The generic name for Guaifenesin is Guaifenesin. There are 12 other brand versions of Guaifenesin.
What is the NDC code for Guaifenesin 600 mg/1?
The NDC (National Drug Code) for Guaifenesin 600 mg/1 is 0363-9569, listed by Walgreens.
Other Guaifenesin Brands
See all →- Guaifenesin and Dextromethorphan Hydrobromide10 mg/5mL72162-2277
- basic care mucus er600 mg/172288-298
- basic care mucus er max1200 mg/172288-613
- Pharbinex-DM20 mg/173057-381
- Mucus Relief DM Extended Release Caplets30 mg/10536-1161
- MUCUS RELIEF - DM MAXIMUM STRENGTH60 mg/173581-405
- BACZOL EXPECTORANT200 mg/5mL76864-209
- Guaifenesin and Pseudoephedrine HCl600 mg/179481-1002
- Meijer Adult Mucus Plus chest congestion200 mg/10mL79481-7430
- Tussin Mucus and Chest Congestion Sugar Free200 mg/10mL82568-0012
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)