HUMANA PHARMACY TUSSIN MULTI SYMPTOM COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

Estados Unidos - inglés - NLM (National Library of Medicine)

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Ficha técnica Ficha técnica (SPC)

03-01-2017

Ingredientes activos:
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Disponible desde:
Humana Pharmacy, Inc.
Designación común internacional (DCI):
DEXTROMETHORPHAN HYDROBROMIDE
Composición:
DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 10 mL
Vía de administración:
ORAL
tipo de receta:
OTC DRUG
indicaciones terapéuticas:
Cough suppressant Expectorant Nasal decongestant
Estado de Autorización:
OTC monograph final
Número de autorización:
70925-516-26

HUMANA PHARMACY TUSSIN MULTI SYMPTOM COLD- dextromethorphan

hydrobromide, guaifenesin, phenylephrine hydrochloride solution

Humana Pharmacy, 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.

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Humana Pharmacy, Inc. Adult Tussin Drug Facts

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Phenylephrine HCl, USP 10 mg

Purpos es

Cough suppressant

Expectorant

Nasal decongestant

Us es

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

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

heart disease

high blood pressure

thyroid disease

diabetes

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

When using this product

do not use more than directed

Stop use and ask a doctor if

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 right away (1-800-222-1222).

Directions

dose

adults and children 12 years and over

10 mL every 4 hours

children under 12 years

do not use

Other information

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, glycerin, propylene glycol, purified

water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Robitussin® Multi-Symptom Cold active ingredients

For Ages 12 & Over

Adult Tussin

Multi-Symptom Cold

you get nervous, dizzy, or sleepless

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

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

headache. A persistent cough may be a sign of a serious condition.

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

measure only with dosing cup provided

keep dosing cup with product

mL = milliliter

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

each 10 mL contains: sodium 5 mg

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

Cough Suppressant

(Dextromethorphan HBr)

Expectorant (Guaifenesin)

Nasal Decongestant

(Phenylephrine HCl)

Relieves:

Cough

Mucus

Nasal Congestion

Cherry Flavor

Non-Drowsy

4 FL OZ (118 mL)

HUMANA PHARMACY TUSSIN MULTI SYMPTOM COLD

dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 9 25-516

Route of Administration

ORAL

Active Ingredient/Active Moiety

Humana Pharmacy, Inc.

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 -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

in 10 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

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

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)

SO DIUM CITRATE, UNSPECIFIED FO RM (UNII: 1Q73Q2JULR)

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

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Product Characteristics

Color

RED (clear)

S core

S hap e

S iz e

Flavor

FRUIT (Mentho l)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 9 25-516 -26

1 in 1 CARTON

12/21/20 16

1

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

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

12/21/20 16

Labeler -

Humana Pharmacy, Inc. (080271087)

Revised: 1/2017

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