GUAIFENESIN 100MG/5ML- guaifenesin solution

Guaifenesin 100mg/5mL by

Drug Labeling and Warnings

Guaifenesin 100mg/5mL by is a Otc medication manufactured, distributed, or labeled by Belleview Biosciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage & Admin

Directions:

■ do not take more than 6 doses in any 24-hour period.

• AGE: DOSE
• Adults & Children 12 years and over: 2-4 teaspoonfuls every 4 hours
• Children 6 years to under 12 years: 1-2 teaspoonfuls every 4 hours
• Children 2 to under 6 years:

  1/2 - 1 teaspoonfuls every 4 hours

• Children Under 2 years: Ask a Doctor

Warnings

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

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 of 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.

INACTIVE INGREDIENT

Inactive Ingredients: Citric Acid, Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

INDICATIONS & USAGE

Uses:

■ helps loosen phlegm (mucus) and thin bronchial secretions to make

coughs more productive

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get

medical help or contact a Poison Control Center right away.

PURPOSE

Purpose: Expectorant

ACTIVE INGREDIENT

Active Ingredient (in each 5 mL tsp)

Guaifenesin 100 mg

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN 100MG/5ML 
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84447-101
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
METHYLPARABEN (UNII: A2I8C7HI9T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84447-101-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2024
2	NDC: 84447-101-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2024
3	NDC: 84447-101-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2024
4	NDC: 84447-101-01	200000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/01/2024

Labeler - Belleview Biosciences (131968803)

Registrant - Belleview Biosciences (131968803)

Establishment
Name	Address	ID/FEI	Business Operations
Belleview Biosciences		131968803	manufacture(84447-101) , label(84447-101) , analysis(84447-101)