Search by Drug Name or NDC

NDC 50383-0063-12 Guaifenesin 100 mg/5mL Details

Guaifenesin 100 mg/5mL

Guaifenesin is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Akorn. The primary component is GUAIFENESIN.

MedlinePlus Drug Summary

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 50383-0063-12
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	50383-0063
Product ID	50383-063_2651ad0c-0f3f-44e2-8273-d480d6f50ecc
Associated GPIs	43200010000910
GCN Sequence Number	022210
GCN Sequence Number Description	guaifenesin LIQUID 100 MG/5ML ORAL
HIC3	B3J
HIC3 Description	EXPECTORANTS
GCN	02512
HICL Sequence Number	000271
HICL Sequence Number Description	GUAIFENESIN
Brand/Generic	Generic
Proprietary Name	Guaifenesin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/5mL
Substance Name	GUAIFENESIN
Labeler Name	Akorn
Pharmaceutical Class	Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50383-0063-12 (50383006312)

Pricing Information	N/A
NDC Package Code	50383-063-12
Billing NDC	50383006312
Package	10 TRAY in 1 CASE (50383-063-12) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE
Marketing Start Date	2012-03-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5cb704a7-301c-494e-948f-872ee0d5a289 Details

Active ingredient

Each 5 mL (1 teaspoonful) contains:

Guaifenesin ................................................ 100 mg

Inactive ingredients

Acesulfame K, artificial cherry & vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

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.
•: you are hypersensitive to any of the ingredients

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.

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Directions

Follow dosage below or use as directed by a physician.

•: do not take more than 6 doses in any 24-hour period

age	dose
adults and children 12 years and over	10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours
children 6 years to under 12 years	5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours
children 2 to under 6 years of age	2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours
children under 2 years of age	ask a doctor

How Supplied:

Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose, 15 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

STORAGE

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

Questions or comments?

Call 1-800-262-9010.

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev.063:01 4/13

MG #29850

Package/Label Principal Display Panel

Delivers 15 mL

NDC 50383-063-15

GUAIFENESIN ORAL SOLUTION

300 mg/15 mL

Sugar Free/Alcohol Free

EXPECTORANT

SEE INSERT

FOR INSTITUTIONAL USE ONLY

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 063:01 4/13

INGREDIENTS AND APPEARANCE

GUAIFENESIN

guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50383-063
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ASPARTAME (UNII: Z0H242BBR1)
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (artificial cherry flavor) , VANILLA (artificial vanilla flavor)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50383-063-06	4 in 1 CASE	03/07/2012	06/05/2017
1	NDC:50383-063-05	10 in 1 TRAY
1		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC:50383-063-07	10 in 1 CASE	03/07/2012
2		10 in 1 TRAY
2		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3	NDC:50383-063-11	4 in 1 CASE	03/07/2012	06/05/2017
3	NDC:50383-063-10	10 in 1 TRAY
3		10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
4	NDC:50383-063-12	10 in 1 CASE	03/07/2012
4		10 in 1 TRAY
4		10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
5	NDC:50383-063-17	4 in 1 CASE	03/07/2012	06/05/2017
5	NDC:50383-063-15	10 in 1 TRAY
5		15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
6	NDC:50383-063-18	10 in 1 CASE	03/07/2012
6		10 in 1 TRAY
6		15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/07/2012

Labeler - Akorn (117696873)

Registrant - Akorn Operating Compnay LLC (117693100)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn		117696873	MANUFACTURE(50383-063) , PACK(50383-063)

Revised: 11/2022

Document Id: 2651ad0c-0f3f-44e2-8273-d480d6f50ecc

Set id: 5cb704a7-301c-494e-948f-872ee0d5a289

Version: 5

Effective Time: 20221115