MAXI-TUSS DM- chlorpheniramine maleate and dextromethorphan hydrobromide liquid
MCR American 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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Maxi-Tuss DM

Drug Facts

Active Ingredients (in each 5 mL teaspoonful)	Purpose
Chlorpheniramine Maleate 4 mg	Antihistamine
Dextromethorphan HBr 18 mg	Cough Suppressant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

cough due to minor throat and bronchial irritation associated with a cold
alleviates cough to help you sleep
non narcotic cough suppressant for relief of cough
itchy, watery eyes
runny nose
sneezing
itching of the nose and throat

Warnings

Do not exceed recommended dosage.
A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

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

Do not take this product, unless directed by a doctor if you have

a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm
a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

Ask a doctor before use if you are taking sedatives or tranquilizers

When using this product

excitability may occur, especially in children
may cause drowsiness
alcohol, sedatives and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

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:	1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:	½ teaspoonful (2.5 mL) every 4 hours, not to exceed 3 teaspoonfuls in 24 hours, or as directed by a doctor
Children under 6 years of age:	Consult a doctor

Other information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

Citric acid, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sorbitol, sucralose, tutti-frutti flavor

Questions or Comments?

Call (352) 754-8587

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 58605-304-16

Maxi-Tuss DM

Antihistamine ◾ Cough Suppressant

Each teaspoonful (5 mL) contains:
Chlorpheniramine Maleate 4 mg
Dextromethorphan HBr 18 mg

Tutti-Frutti Flavor

Alcohol Free ◾ Sugar Free ◾ Dye Free

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

16 fl oz (473 mL)

Principal Display Panel - 473 mL Bottle Label

MAXI-TUSS DM
chlorpheniramine maleate and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58605-304
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg in 5 mL
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	18 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Methylparaben (UNII: A2I8C7HI9T)
Potassium Citrate (UNII: EE90ONI6FF)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Sucralose (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	TUTTI FRUTTI	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58605-304-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2018	09/30/2020
2	NDC:58605-304-10	10 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2018	09/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	04/01/2018	09/30/2020

Labeler - MCR American Pharmaceuticals, Inc. (783383011)

Name	Address	ID/FEI	Business Operations
Establishment
MCR American Pharmaceuticals, Inc.		783383011	MANUFACTURE(58605-304)

Revised: 1/2021

Document Id: 930912b3-5705-416a-acfa-eea34271749c

Set id: 387b9e77-817a-42a8-a745-4a69d2029e9a

Version: 2

Effective Time: 20210114

MCR American Pharmaceuticals, Inc.