Q-TUSSIN- guaifenesin solution
Preferred Pharmaceuticals, Inc

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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Q-Tussin 0857

Active ingredient (in each 5 mL = 1 tsp)

Guaifenesin, USP 100 mg

Purpose

Expectorant

Use

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
•: this adult product is not intended for use in children under 12 years of age

age (yr)	dose (tsp)
adults and children 12 years and over	2 - 4 teaspoons every 4 hours
children under 12 years	do not use

Other information

•: each tsp contains: sodium 2 mg
•: store at 15° to 30°C (59° to 86°F)
•: dosage cup provided

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

caramel color, FD&C red #40, flavor, glycerin, liquid glucose, purified water, saccharin sodium, sodium benzoate

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 5/09 R7
8273611 0857

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL

Q-TUSSIN
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68788-9081(NDC:0603-0857)
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
CARAMEL (UNII: T9D99G2B1R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	ORANGE (clear, reddish-orange)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68788-9081-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/01/1997	12/02/2020

Labeler - Preferred Pharmaceuticals, Inc (791119022)

Registrant - Preferred Pharmaceuticals, Inc (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals, Inc		791119022	RELABEL(68788-9081)

Revised: 12/2020

Document Id: ee99c287-c545-4e83-bfe5-ec4abccd3950

Set id: 36231ec1-97c0-4931-a689-ac74268a6bb7

Version: 6

Effective Time: 20201202

Preferred Pharmaceuticals, Inc