Tussin CF — v2

Tussin CF

6 Views

Version

v2

Effective date

January 7, 2025

Original packager

Yes

Sections captured

15

Identifiers

Document ID
2b1ddb46-8ca9-5e1c-e063-6294a90a6b77
Set ID
e416982f-6cbb-4f48-a215-16bea8393dad
Application numbers
part341
Product NDCs
70677-1187
Package NDCs
70677-1187-1
Original packager NDCs
—

Names & Manufacturers

Brand names
Tussin CF
Generic names
DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL
Manufacturer names
Strategic Sourcing Services
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Routes
ORAL
Pharmacologic class (PE)
Decreased Respiratory Secretion Viscosity [PE], Increased Respiratory Secretions [PE]
Pharmacologic class (EPC)
Expectorant [EPC]
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
N0000008867, N0000009560, N0000193956
RxCUI
1044949
UNII
04JA59TNSJ, 495W7451VQ, 9D2RTI9KYH
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredients (in each 10 mL) Dextromethorphan HBrDextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg Phenylephrine HCI, USP 10 mg
Ask Doctor (1)

Sequence 1

Ask a doctor before use if you have ■ 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 Doctor Or Pharmacist (1)

Sequence 1

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.
Dosage And Administration (1)

Sequence 1

Directions ■ 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
Dosage And Administration Table (1)

Sequence 1

AGE DOSE
Adults and children 12 years and over 10 mL every 4 hours
Children under 12 years do not use
Inactive Ingredient (1)

Sequence 1

Inactive ingredients anhydrous citric acid, FD&C red no.40, glycerin, menthol, natural & artificial flavor, propylene glycol,purified water, sodium benzoate, sorbitol solution, sucralose
Indications And Usage (1)

Sequence 1

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.
Keep Out Of Reach Of Children (1)

Sequence 1

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).
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL Dextromethorphan HBr Guaifenesin Phenylephrone HCL-237 mL Dextromethorphan HBr Guaifenesin Phenylephrone HCL-237 mL
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast feeding ask a health professional before use.
Purpose (1)

Sequence 1

Purposes Cough suppressant Expectorant Nasal decongestant
Spl Product Data Elements (1)

Sequence 1

Tussin CF Dextromethorphan HBr Guaifenesin Phenylephrine HCl ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN MENTHOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SOLUTION SUCRALOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE
Spl Unclassified Section (2)

Sequence 1

Other information ■ 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

Sequence 2

Questions or comments? Call 833-358-6431 Monday 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 ®
Stop Use (1)

Sequence 1

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.
Warnings (1)

Sequence 1

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.

OpenFDA raw payload

{'application_number': ['part341'],
 'brand_name': ['Tussin CF'],
 'generic_name': ['DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL'],
 'is_original_packager': [True],
 'manufacturer_name': ['Strategic Sourcing Services'],
 'nui': ['N0000193956', 'N0000008867', 'N0000009560'],
 'package_ndc': ['70677-1187-1'],
 'pharm_class_epc': ['Expectorant [EPC]'],
 'pharm_class_pe': ['Decreased Respiratory Secretion Viscosity [PE]',
                    'Increased Respiratory Secretions [PE]'],
 'product_ndc': ['70677-1187'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'rxcui': ['1044949'],
 'spl_id': ['2b1ddb46-8ca9-5e1c-e063-6294a90a6b77'],
 'spl_set_id': ['e416982f-6cbb-4f48-a215-16bea8393dad'],
 'substance_name': ['DEXTROMETHORPHAN HYDROBROMIDE',
                    'GUAIFENESIN',
                    'PHENYLEPHRINE HYDROCHLORIDE'],
 'unii': ['9D2RTI9KYH', '495W7451VQ', '04JA59TNSJ']}