Y-TUSS

Manufacturer
Magna Pharmceuticals, Inc. | Woodfield Pharmaceutical, LLC
Effective date
2020-10-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:10:14

Label at a glance#

ProductY-TUSS
Active ingredientBROMPHENIRAMINE MALEATE, CHLOPHEDIANOL HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure18 sections

Storage and handling

Other information Store at 59° - 86°F (15° - 30°C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 5mL teaspoonful)

Brompheniramine Maleate 2 mg

Chlophedianol Hydrochloride 12.5 mg

Pseudoephedrine Hydrochloride 30 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

Do not exceed recommended dosage.

OTC - DO NOT USE SECTION

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 physician or pharmacist before taking this product.

OTC - ASK DOCTOR SECTION

Ask a physician before use if you have

  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a physician if

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

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

DOSAGE & ADMINISTRATION SECTION

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:

2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teapoonfuls (40 mL) in

24 hours.

Children 6 to under

12 years of age:

1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls (20 mL) in

24 hours.

Children under

6 years of age:

Consult a physician

STORAGE AND HANDLING SECTION

Other information

Store at 59° - 86°F (15° - 30°C)

INACTIVE INGREDIENT SECTION

Inactive ingredients

Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

OTC - QUESTIONS SECTION

Questions? Comments?

Call your physician for medical advice. Serious side effects associated with this product may be reported to this number. 1-888-206-5525, 8 am - 5 pm, M-F EST

SPL UNCLASSIFIED SECTION

Manufactured for:

MAGNA

Phamaceuticals, Inc.

Accountability.

Louisville, KY 40299

magnaweb.com

Rev. 07/19

Y-TUSS 4fl oz (118 mL) Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Y-Tuss sample label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

samplesample

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58407-302-04ML - Milliliter58407-302bb21f9e7-30dd-4e08-b8ea-fceb298e057e12019-09-05

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58407-30258407-302-04, 58407-302-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b244b976-e5d4-9993-e053-2995a90ab6bf90ba0085-f355-d773-e053-2995a90a8cac2020-10-22WarningsExact identifier
spl id: b244b976-e5d4-9993-e053-2995a90ab6bf
spl set id: 90ba0085-f355-d773-e053-2995a90a8cac

Reported adverse events (FAERS/openFDA)#

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