MAXI-TUSS DM- chlorpheniramine maleate and dextromethorphan hydrobromide liquid

Maxi-Tuss DM by

Drug Labeling and Warnings

Maxi-Tuss DM by is a Otc medication manufactured, distributed, or labeled by MCR American Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - MCR American Pharmaceuticals, Inc. (783383011)

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