FDA.reportPublic FDA data

Tussin CF

Manufacturer
Strategic Sourcing Services | AptaPharma Inc.
Effective date
2025-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:51:15

Label at a glance#

ProductTussin CF
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure14 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

■ mL = milliliter ■ do not take more than 6 doses in any 24 hour period ■ this adult strength product is not intended for use in children under 12 years of age ■ measure only with dosing cup provided ■ keep dosing cup with product AGE DOSE Adults and children 12 years and over 10 mL every 4 hours Children under 12 years do not use

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION


Dextromethorphan HBrDextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg
Phenylephrine HCI, USP 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

SPL UNCLASSIFIED 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
■ thyroid disease        ■ diabetes
■ trouble urinating due to 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 do not use more than directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION


■ 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

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

Directions

DOSAGE & ADMINISTRATION SECTION


■ mL = milliliter
■ do not take more than 6 doses in any 24 hour period
■ this adult strength product is not intended for use in children under 12 years of age
■ measure only with dosing cup provided
■ keep dosing cup with product


AGE
DOSE
Adults and children 12 years and over
10 mL every 4 hours
Children under 12 years
do not use

Other information

SPL UNCLASSIFIED SECTION


■ each 10 mL contains: sodium 6 mg
■ store at 20-25°C (68-77°F)       ■ do not refrigerate
■ Keep carton for full Direction for use

Inactive ingredients

INACTIVE INGREDIENT SECTION


anhydrous citric acid, FD&C red no.40, glycerin, menthol, natural & artificial flavor, propylene glycol,purified water, sodium benzoate, sorbitol solution, sucralose

Questions or comments?

SPL UNCLASSIFIED SECTION


Call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

©2023 McKesson Corporation
Distributed by:McKesson Corp., via Strategic Sourcing Services LLC.
Memphis, TN 38141
Money Back Guarantee
www.fosterandthrive.com

*This product is not manufactured or distributed by Pfizer,
owner of the registered trademark Robitussin ®

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dextromethorphan HBr Guaifenesin Phenylephrone HCL-237 mL

Dextromethorphan HBr Guaifenesin Phenylephrone HCL-237 mLDextromethorphan HBr Guaifenesin Phenylephrone HCL-237 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044949dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral SolutionPSN2
1044949dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral SolutionSCD2
1044949dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral SolutionSY2
1044949dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1187-1Tussin CF1 in 1 CARTONSOLUTION12
70677-1187-1Tussin CF237 mL in 1 BOTTLESOLUTION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1187TUSSIN CF (DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL) SOLUTION [STRATEGIC SOURCING SERVICES]2Current NDC, 2 package rows20250109_e416982f-6cbb-4f48-a215-16bea8393dad.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1187-1ML - Milliliter70677-1187ec31015c-5927-496d-8415-e1e2bad3c45012023-09-05

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-118770677-1187-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL SOLUTION8KW3E207O2IACT
SUCRALOSE96K6UQ3ZD4IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLStrategic Sourcing Servicese416982f-6cbb-4f48-a215-16bea8393dad2025-01-07WarningsExact identifier
ndc (package): 70677-1187-1
ndc (product): 70677-1187
ndc11 (package): 70677118701
spl id: 2b1ddb46-8ca9-5e1c-e063-6294a90a6b77
spl set id: e416982f-6cbb-4f48-a215-16bea8393dad

Reported adverse events (FAERS/openFDA)#

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