Guaifenesin Liquid
FDA Label NDC 58657-509

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 58657-509). 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 active ingredient (in each 5 ml), purpose, uses, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., directions, 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

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)

Principal Display Panelndc 58657- 509- 16guaifenesinliquid Usp100 mg/ 5 mLexpectorant16 Fl. Oz. (473 mL) (Guaifenesin 01)

Principal Display Panelndc 58657- 509- 16guaifenesinliquid Usp100 mg/ 5 mLexpectorant16 Fl. Oz. (473 mL) (Guaifenesin 01)

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