Other
NDC 58657-508-16
Guaifenesin
Liquid USP
100 mg/5 Ml
Expectorant
Sugar Free • Alcohol Free
Cherry Flavor
Loosens and Relieves Chest Congestion
16 fl. oz. (473 mL)
Drug Facts
Guaifenesin Liquid
FDA Label NDC 58657-508
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Method Pharmaceuticals, Llc for the product Guaifenesin (NDC 58657-508). 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 5 ml), purpose, uses, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5 Ml)
Guaifenesin 100 mg
Purpose
Expectorant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.
Ask A Doctor Before Use If You Have
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
When Using This Product
- Do not use more than directed
Stop Use And Ask A Doctor If
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
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
age dose adults and children 12 years and over 2 to 4 teaspoonfuls every 4 hours children 6 years to under 12 years 1 to 2 teaspoonfuls every 4 hours children 2 to under 6 yars 1/2 to 1 teaspoonful every 4 hours children under 2 years ask a doctor
Other Information
- store at 20°-25°C (68°-77°F)
- packaged with tamper evident seal under cap
- each 5 mL contains: sodium 3 mg
Inactive Ingredients
Caramel, citric acid anhydrous, dextrose, FD&C red #40, flavor, gylcerin, high fructose corn syrup, menthol, purified water, saccharin, sodium, sodium benzoate
Questions Or Comments
1-877-250-3427
Manufactured For:
Method Pharmaceuticals, LLC
Southlake, TX 79092
LR-205
Rev-2024
Principal Display Panel
NDC 58657- 508- 16
Guaifenesin
Liquid USP
100 mg/ 5 mL
Expectorant
16 fl. oz. (473 mL)
Label (Guaifensin Liquid)
* Please review the disclaimer below.
