Drug Facts

Active Ingredients (in each 5 mL teaspoonful)	Purpose
Dextromethorphan HBr 10 mg	Cough Suppressant
Guaifenesin 200 mg	Expectorant

Uses

temporarily relieves

cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
the intensity of coughing
the impulse to cough to help you get to sleep

Warnings

Do not exceed recommended dosage.

Do not use this product

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if you have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
cough that occurs with too much phlegm (mucus)

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 accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:	2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours or as directed by a doctor
Children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours or as directed by a doctor
Children under 6 years of age:	Consult a physician

Other information

Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

Inactive ingredients

Cherry flavor, citric acid, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylparaben, propylene glycol, purified water, sorbitol, sucralose

Questions or comments?

Call 352.754.8587

Principal Display Panel - 473 mL Bottle Label

NDC 58605-312-16

Maxi-Tuss GMX
Cough Suppressant ■ Expectorant

Sugar Free ■ Alcohol Free ■ Dye Free

Each teaspoonful (5 mL) for oral administration
contains:
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg

Cherry Flavor

Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Manufactured for:
MCR American Pharmaceuticals, Inc.
Brooksville, FL 34604

16 fl oz (473 mL)

Principal Display Panel - 473 mL Bottle Label

MAXI-TUSS GMX
dextromethorphan hydrobromide and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58605-312
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Methylparaben (UNII: A2I8C7HI9T)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
Potassium Citrate (UNII: EE90ONI6FF)
Propylparaben (UNII: Z8IX2SC1OH)
Propylene Glycol (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58605-312-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/01/2020

Labeler - MCR American Pharmaceuticals, Inc. (783383011)

Name	Address	ID/FEI	Business Operations
Establishment
MCR American Pharmaceuticals, Inc.		783383011	MANUFACTURE(58605-312)