FDA Label for Guaifenesin
View Indications, Usage & Precautions
Guaifenesin Product Label
The following document was submitted to the FDA by the labeler of this product Method Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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 2 to 4 teaspoonfuls
12 years and over every 4 hours
children 6 years to 1 to 2 teaspoonfuls
under 12 years every 4 hours
children 2 years to ½ to 1 teaspoonful
under 6 years every 4 hours
children under 2 years ask a doctor
Drug Facts (continued)
Other Information
- store at 20°-25°C (68°-77°F)
- packaged with tamper evident seal under cap
Inactive Ingredients
Bitter Mask, Cherry Flavor, Citric Acid, FD&C Red#40, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution
Questions Or Comments
1-877-250-3427
Manufactured For:
Method Pharmaceuticals, LLC
Fort Worth, Texas 76118 Rev. 09/16
Principal Display Panel
NDC 58657- 509- 16
Guaifenesin
Liquid USP
100 mg/ 5 mL
Expectorant
16 fl. oz. (473 mL)
* Please review the disclaimer below.