Tussin Multi Symptom Cold CF

Manufacturer: Preferred Pharmaceuticals Inc.
Effective date: 2022-09-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-01 21:26:05

Label at a glance#

ProductTussin Multi Symptom Cold CF Adult

Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Label structure10 sections

Indications and 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

Dosage and administration

• 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

Storage and handling

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

Contacts and useful links#

PhonePoison Help1800-222-1222

PhoneLabel contact1-877-753-3935

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other oral nasal decongestant or stimulant.

When using this product,

OTC - WHEN USING SECTION

do not use more than directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.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 Years 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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Relabeled By: Preferred Pharmaceuticals Inc.

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1044949	Dextromethorphan/guaiFENesin/Phenylephrine (Oral Liquid)	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution	SCD Active

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6537-20	ML - Milliliter	0904-6537	be84ba7f-5f37-4d97-ad3f-2c45c64a5d53	1	2016-02-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

Tussin Multi Symptom Cold CF Adult
Dextromethorphan HBr, Guaifenesin, Phenylephrine
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
GUAIFENESIN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
ANHYDROUS CITRIC ACID
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
FD&C RED NO. 40
LACTIC ACID, UNSPECIFIED FORM
MENTHOL, UNSPECIFIED FORM
SORBITOL
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68788-8142	68788-8142-1
0904-6537

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
GUAIFENESIN	495W7451VQ	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
LACTIC ACID, UNSPECIFIED FORM	33X04XA5AT	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	IACT
SORBITOL	506T60A25R	IACT
SUCRALOSE	96K6UQ3ZD4	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tussin Multi Symptom Cold CF Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE	Major Pharmaceuticals	a9958b7d-7060-422b-a098-c1925c246081	2025-12-17	Warnings	Exact identifier ndc (product): 0904-6537
06093a4c-689a-473a-a488-76cf01ee2ec5			40e7b36f-b258-4381-96d1-9d7176c43df9	2025-01-17	Warnings	Exact identifier spl set id: 40e7b36f-b258-4381-96d1-9d7176c43df9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.