Drug Facts

Active Ingredients (in each 5 mL teaspoonful)	Purpose
Pseudoephedrine HCl 30 mg	Nasal Decongestant
Triprolidine HCl 1.25 mg	Antihistamine

Uses

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

runny nose
sneezing
itching of the nose or throat
itchy, watery eyes
nasal congestion
reduces swelling of nasal passages

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

a breathing problem such as emphysema or chronic bronchitis
glaucoma
heart disease
high blood pressure
thyroid disease
diabetes mellitus
difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist 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

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or are accompanied by fever
new symptoms occur

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 4-6 hours, not to exceed 8 teaspoonfuls in 24 hours
Children 6 to under 12 years of age:	1 teaspoonful (5 mL) every 4-6 hours, not to exceed 4 teaspoonfuls in 24 hours
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

Bubblegum 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 58605-305-16

Maxi-Tuss TR

Nasal Decongestant ◾ Antihistamine

Sugar Free ◾ Alcohol Free ◾ Dye Free

Each teaspoonful (5 mL) for oral administration
contains:
Pseudoephedrine HCl
30 mg
Triprolidine HCl
1.25 mg

Bubblegum 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 TR
pseudoephedrine hydrochloride and triprolidine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58605-305
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	Pseudoephedrine Hydrochloride	30 mg in 5 mL
Triprolidine Hydrochloride (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	Triprolidine Hydrochloride	1.25 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	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58605-305-16	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(58605-305)