EQUALINE TUSSIN COUGH AND COLD- dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride liquid
Supervalu 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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Active ingredient (in each 5 mL tsp)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 5 mg

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Uses

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
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

you get nervous, dizzy, or sleepless
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 right away. (1-800-222-1222)

Directions

do not take more than 6 doses in any 24-hour period
this adult product is not intended for use in children under 12 years of age
mL = milliliter; tsp = teaspoonful

age	dose
adults and children 12 years and over	10 mL (2 tsp) every 4 hours
children under 12 years	do not use

Other information

each teaspoon contains: sodium 3 mg
store at 20º-25ºC (68º-77ºF)

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?

1-877-932-7948

Principal Display Panel

compare to Robitussin® Cough & Cold CF active ingredients

adult

tussin cough & cold

dextromethorphan HBr (cough suppressant)

guaifenesin (expectorant)

phenylephrine HCl (nasal decongestant)

non-drowsy

relieves:
cough

stuffy nose

chest congestion/mucus

for ages 12 & over

alcohol free

Tussin Cough & Cold Carton Image 1

Tussin Cough & Cold Carton Image 2

EQUALINE TUSSIN COUGH AND COLD
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-516
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg in 5 mL
GUAIFENESIN (GUAIFENESIN)	GUAIFENESIN	100 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	5 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID
EDETATE DISODIUM
FD&C RED NO. 40
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SODIUM CITRATE
SORBITOL
SUCRALOSE

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:41163-516-26	1 in 1 CARTON
1		118 mL in 1 BOTTLE
2	NDC:41163-516-34	1 in 1 CARTON
2		237 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/29/2006

Labeler - Supervalu Inc (006961411)

Revised: 11/2011

Document Id: 42e3f060-2e52-49cd-ae48-66f22a0e4ea5

Set id: 42e3f060-2e52-49cd-ae48-66f22a0e4ea5

Version: 1

Effective Time: 20111101

Supervalu Inc