Guaifenesin by Oncor Pharmaceuticals GUAIFENESIN liquid

Guaifenesin by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient (in each 5 mL teaspoonful)

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

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: 2-4 Teaspoonfuls every 4 hours
  • Children 6 years to under 12 years: 1-2 Teaspoonfuls every 4 hours
  • Children 2 years to under 6 years: 1/2-1 Teaspoonful every 4 hours
  • Under 2 years: Ask a doctor

Drug Facts(continued)

Other information

• store at 20°-25°C (68°-77°F)
• Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
• sodium content 3 mg/5 mL

Inactive ingredients

Citric acid, Cherry flavor, FD&C red No. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium, sorbitol solution, sucralose.

Questions?

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Manufactured for:
Oncor Pharmaceuticals
8815 Center Park Dr. Suite 430
Columbia, Maryland 21045

Rev. 05/24

PRINCIPAL DISPLAY PANEL

NDC 83720-503-16

ONCOR PHARMACEUTICALS

Guaifenesin

Oral Solution USP

100 mg/5 mL

Expectorant

Relieves Chest Congestion

Sugar Free Alcohol Free

Cherry Flavor

16 fl. oz. - 473 mL

INGREDIENTS AND APPEARANCE

GUAIFENESIN 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83720-503
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM (UNII: 9NEZ333N27)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83720-503-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/10/2024

Labeler - Oncor Pharmaceuticals (119032580)

Registrant - Oncor Pharmaceuticals (119032580)