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Tussin Multi Symptom Cold CF Adult

Medically reviewed on January 19, 2017

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg in 10mL, GUAIFENESIN 200mg in 10mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 10mL
Labeler: Preferred Pharmaceuticals Inc.
NDC Code: 68788-6872

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

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
diabetes
thyroid
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 (1800-222-1222) right away.

Directions
do not take more than 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
adult and children 12 years and over: 10 mL every 4 hours
children under 12 years: do not use

Other information
store between 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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

ROBAFEN

CF MULTI-SYMPTOM COLD

Dextromethorphan HBr, 20 mg /  COUGH SUPPRESSANT

Guaifenesin, 200 mg / EXPECTORANT

Phenylephrine HCl, 10 mg / NASAL DECONGESTANT

PEAK COLD

Relieves:

Cough
Mucus
Nasal Congestion

Non-Drowsy

COMPARE TO the active ingredients in ROBITUSSIN® PEAK COLD MULTI-SYMPTOM COLD CF*

FOR ADULTS

For Ages 12 and Over

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.

Distributed by:

MAJOR PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

Relabeled By: Preferred Pharmaceuticals Inc.

Package Label

Major CF Multi-Symptom Cold

TUSSIN MULTI SYMPTOM COLD CF  ADULT
dextromethorphan hbr, guaifenesin, phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-6872(NDC:0904-6537)
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 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
FD&C RED NO. 40 
LACTIC ACID, UNSPECIFIED FORM 
MENTHOL, UNSPECIFIED FORM 
SORBITOL 
SUCRALOSE 
Packaging
#Item CodePackage Description
1NDC:68788-6872-11 BOTTLE, PLASTIC in 1 BOX
1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/19/2017
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-6872)

 
Preferred Pharmaceuticals Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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