Y-TUSS- brompheniramine maleate, chlophedianol hydrochloride, pseudoephedrine hydrochloride liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN), CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP), PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)
Available from:
Magna Pharmceuticals, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antihistamine Cough Suppressant Nasal Decongestant 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 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. 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.
Authorization status:
OTC monograph final
Authorization number:
58407-302-01, 58407-302-04

Y-TUSS- brompheniramine maleate, chlophedianol hydrochloride, pseudoephedrine

hydrochloride liquid

Magna Pharmceuticals, 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.

----------

Y-TUSS

Drug Facts

Active ingredients

(in each 5mL teaspoonful)

Brompheniramine Maleate 2 mg

Chlophedianol Hydrochloride 12.5 mg

Pseudoephedrine Hydrochloride 30 mg

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

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

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

physician or pharmacist before taking this product.

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

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

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

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.

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

Keep out of the reach of children.

In case of an 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 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

Other information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

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

Saccharin, Sorbitol.

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

Manufactured for:

MAGNA

Phamaceuticals, Inc.

Accountability.

Louisville, KY 40299

magnaweb.com

Rev. 07/19

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

Y-Tuss sample label

Y-TUSS

brompheniramine maleate, chlophedianol hydrochloride, pseudoephedrine hydrochloride liquid

Magna Pharmceuticals, Inc.

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 40 7-30 2

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BRO MPHENIRAMINE MALEATE (UNII: IXA7C9 ZN0 3) (BROMPHENIRAMINE -

UNII:H57G17P2FN)

BROMPHENIRAMINE

MALEATE

2 mg

in 5 mL

CHLO PHEDIANO L HYDRO CHLO RIDE (UNII: 6 9 QQ58 9 9 8 Y) (CHLOPHEDIANOL -

UNII:42C50 P12AP)

CHLOPHEDIANOL

HYDROCHLORIDE

12.5 mg

in 5 mL

PSEUDO EPHEDRINE HYDRO CHLO RIDE (UNII: 6 V9 V2RYJ8 N)

(PSEUDOEPHEDRINE - UNII:7CUC9 DDI9 F)

PSEUDOEPHEDRINE

HYDROCHLORIDE

30 mg

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

SO RBITO L (UNII: 50 6 T6 0 A25R)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 40 7-30 2-0 4

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /20 /20 19

10 /31/20 20

2

NDC:58 40 7-30 2-0 1

15 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /20 /20 19

10 /31/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 8 /20 /20 19

10 /31/20 20

Labeler -

Magna Pharmceuticals, Inc. (620988360)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Wo o dfield Pharmaceutical, LLC

0 79 39 8 730

ma nufa c ture (58 40 7-30 2)

Revised: 10/2020

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