MAXI-TUSS GMX- dextromethorphan hydrobromide and guaifenesin liquid

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

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.

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

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)

INGREDIENTS AND APPEARANCE

MAXI-TUSS GMX
dextromethorphan hydrobromide and guaifenesin liquid

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)

#	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)

Maxi-Tuss GMX by