TUSSIN MULTI SYMPTOM COLD CF- dextromethorphan hbr, guaifenesin, phenylephrine liquid

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

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Active ingredient:
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Best Choice (Valu Merchandisers Company)
INN (International Name):
DEXTROMETHORPHAN HYDROBROMIDE
Composition:
DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 10 mL
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Cough suppressant Expectorant Nasal decongestant - helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes - temporarily relieves these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation - nasal congestion - cough due to minor throat and bronchial irritation
Authorization status:
OTC monograph final
Authorization number:
63941-382-04

TUSSIN MULTI SYMPTOM COLD CF- dextromethorphan hbr, guaifenesin,

phenylephrine liquid

Best Choice (Valu Merchandisers Company)

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.

----------

Drug Facts

Active ingredients (in each 10 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

Purpos es

Cough suppressant

Expectorant

Nasal decongestant

Us es

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

temporarily relieves these symptoms occurring with a cold:

nasal congestion

cough due to minor throat and bronchial irritation

Warnings

Do not use

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

heart disease

diabetes

high blood pressure

thyroid disease

trouble urinating due to an enlarged prostate gland

cough that occurs with too much phlegm (mucus)

cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or

emphysema

Ask a doctor or pharmacist before use if you are

taking any other oral nasal decongestant or stimulant.

When using this product,

do not use more than directed.

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur

symptoms do not get better within 7 days or are accompanied by fever

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

do not take more then 6 doses in any 24-hour period

measure only with dosing cup provided. Do not use any other dosing device.

keep dosing cup with product

mL=milliliter

this adult product is not intended for use in children under 12 years of age

adults and children 12 years and over: 10 mL every 4 hours

children under 12 years: do not use

Other information

store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, FD&C red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified

water, sodium benzoate, sorbitol, sucralose

Principal Display Panel

For Ages 12 Years and Over

COMPARE TO THE ACTIVE INGREDIENTS IN ROBITUSSIN® PEAK COLD MULTI-

SYMPTOM COLD CF*

Tus s in

MULTI-SYMPTOM COLD CF

Dextromethorphan HBr

Cough Suppressant

Guaifenesin

Expectorant

Phenylephrine HCl

Nasal Decongestant

Relieves:

Cough

Mucus

Nasal Congestion

NON-DROWSY

Alcohol-Free

FL OZ (mL)

Dosing Cup Included

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of

Robitussin® Peak Cold Multi-Symptom Cold CF.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY

SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

5000 KANSAS AVE

KANSAS CITY, KS 66106

www.bestchoicebrand.com

Package Label

Best Choice Tussin Multi-Symptom Cold CF Liquid

TUSSIN MULTI SYMPTOM COLD CF

dextromethorphan hbr, guaifenesin, phenylephrine liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 39 41-38 2

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

20 mg

in 10 mL

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

20 0 mg

in 10 mL

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

PHENYLEPHRINE

10 mg

Best Choice (Valu Merchandisers Company)

UNII:1WS29 7W6 MV)

HYDROCHLORIDE

in 10 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

GLYCERIN (UNII: PDC6 A3C0 OX)

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

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

LACTIC ACID (UNII: 33X0 4XA5AT)

MENTHO L (UNII: L7T10 EIP3A)

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

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 39 41-38 2-

1 in 1 BOX

0 2/28 /20 15

0 2/28 /20 21

1

118 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 2/28 /20 15

0 2/28 /20 21

Labeler -

Best Choice (Valu Merchandisers Company) (868703513)

Revised: 7/2019

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