Guaifenesin by Method Pharmaceuticals, LLC GUAIFENESIN liquid

Guaifenesin by

Drug Labeling and Warnings

Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Method Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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.

Warnings

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)

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58657-508
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
CARAMEL (UNII: T9D99G2B1R)
DEXTROSE (UNII: IY9XDZ35W2)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58657-508-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/01/2024

Labeler - Method Pharmaceuticals, LLC (060216698)