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NDC 61787-0514-04 Diabetic Tussin Expectorant 200 mg/10mL Details

Diabetic Tussin Expectorant 200 mg/10mL

Diabetic Tussin Expectorant is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by MEDTECH PRODUCTS INC. 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: 61787-0514-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	61787-0514
Product ID	61787-514_27e059a5-ece3-4fa7-8f12-59ae0c21bdd4
Associated GPIs
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	Diabetic Tussin Expectorant
Proprietary Name Suffix	n/a
Non-Proprietary Name	Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/10mL
Substance Name	GUAIFENESIN
Labeler Name	MEDTECH PRODUCTS INC
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	2024-12-31

Package

Package Images

NDC 61787-0514-04 (61787051404)

Pricing Information	N/A
NDC Package Code	61787-514-04
Billing NDC	61787051404
Package	1 BOTTLE in 1 BOX (61787-514-04) / 118 mL in 1 BOTTLE
Marketing Start Date	2020-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc Details

SPL UNCLASSIFIED SECTION

DIABETIC TUSSIN EXPECTORANT- guaifenesin liquid

Medtech Products Inc., a Prestige Consumer Healthcare company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each 10 mL)

Guaifenesin 200 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

Warnings

Ask a doctor before use if you have:

a cough that occurs with too much phlegm (mucus)
a persistent or chronic cough 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 occurs with fever, rash, or headache that lasts

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

take every 4 hours
do not exceed 6 doses in 24 hours

Adults	10 mL - 20 mL (2 - 4 teaspoons)
Children under 12 years	ask a doctor

Other information

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
store at room temperature 20-25°C (68-77°F).
keep tightly closed.

Inactive ingredients

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

Questions or comments?

Call 1-800-579-8327, serious side effects associated with use of this product may be reported to this number.

Rev #0514:00 04/19

Principal Display Panel

SUGAR & ALCOHOL FREE!

Specifically Formulated for Diabetics

Diabetic Tussin®

CHEST CONGESTION

Guaifenesin (Expectorant)

Thins & Loosens Mucus

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

DIABETIC TUSSIN EXPECTORANT

guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61787-514
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ASPARTAME (UNII: Z0H242BBR1)
CHERRY (UNII: BUC5I9595W)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
VANILLA (UNII: Q74T35078H)
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
Packaging
1	NDC:61787-514-04	1 in 1 BOX	02/01/2020
1		118 mL in 1 BOTTLE; 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	02/01/2020

Labeler - MEDTECH PRODUCTS INC (114707784)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn Operating Company LLC (dba Akorn)		117696873	manufacture(61787-514)

Revised: 3/2022

Document Id: 27e059a5-ece3-4fa7-8f12-59ae0c21bdd4

Set id: d65f7ad8-8dbc-4a29-8b42-0c6d5d7f4ffc

Version: 3

Effective Time: 20220307