Maxi-Tuss TR

Label at a glance#

Contacts and useful links#

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Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use this product

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 352.754.8587

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

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FDA-Initiated Inactive NDC Indexing#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

• Maxi-Tuss TR
• Pseudoephedrine Hydrochloride and Triprolidine Hydrochloride
• Pseudoephedrine Hydrochloride
• PSEUDOEPHEDRINE
• Triprolidine Hydrochloride
• TRIPROLIDINE
• CITRIC ACID MONOHYDRATE
• Methylparaben
• AMMONIUM GLYCYRRHIZATE
• Potassium Citrate
• Propylparaben
• Propylene Glycol
• WATER
• Sorbitol
• Sucralose

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.