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healthy accents tussin cf

Dosage form: solution
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg in 10mL, GUAIFENESIN 200mg in 10mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 10mL
Labeler: DZA Brands LLC
NDC Code: 55316-516

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.

DZA Brands, LLC Tussin CF Drug Facts

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Phenylephrine HCl, USP 10 mg

Purposes

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. A persistent cough may be a sign 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
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

age

dose

adults and children 12 years and over

10 mL every 4 hours

children under 12 years

do not use

Other information
each 10 mL contains: sodium 5 mg
store at 20-25ºC (68-77ºF)

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?

1-866-322-2439

Principal Display Panel

PEAK COLD

adult

tussin CF

cold multi-symptom

cough suppressant (dextromethorphan HBr)

expectorant (guaifenesin)

nasal decongestant (phenylephrine HCl)

non-drowsy

for ages 12 & over

relieves:

cough

mucus

nasal congestion

Compare to Robitussin® Multi-Symptom Cold active ingredients

gluten free

alcohol free

4 FL OZ (118mL)

HEALTHY ACCENTS TUSSIN CF 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-516
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C RED NO. 40 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorRED (clear) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55316-516-261 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/04/2008
Labeler - DZA Brands LLC (090322194)

Revised: 07/2014
 
DZA Brands LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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