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NDC 76281-0311-26 Tussin CF 20; 200; 10 mg/10mL; mg/10mL; mg/10mL Details

Tussin CF 20; 200; 10 mg/10mL; mg/10mL; mg/10mL

Tussin CF is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by AptaPharma Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 76281-0311-26
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 76281-0311-26
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 76281-0311-26
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	76281-0311
Product ID	76281-311_ca064f73-10bd-4354-9ce7-a1c0b7b01da5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Tussin CF
Proprietary Name Suffix	n/a
Non-Proprietary Name	DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCl
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	20; 200; 10
Active Ingredient Units	mg/10mL; mg/10mL; mg/10mL
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	AptaPharma Inc.
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2022-12-31

Package

Package Images

NDC 76281-0311-26 (76281031126)

Pricing Information	N/A
NDC Package Code	76281-311-26
Billing NDC	76281031126
Package	237 mL in 1 BOTTLE (76281-311-26)
Marketing Start Date	2018-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0da76857-71ab-433d-9ad9-415ed94ce5ff Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Phenylephrine HCl 10 mg

SPL UNCLASSIFIED SECTION

Purpose

Dextromethorphan HBr, USP Cough suppressant

Guaifenesin, USP Expectorant

Phenylephrine HCl Nasal Decongestant

SPL UNCLASSIFIED SECTION

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 bronch

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Ask a doctor or pharmacist before use if you are taking any

other oral nasal decongestant or stimulant

SPL UNCLASSIFIED SECTION

When using this product do not use more than directed

SPL UNCLASSIFIED SECTION

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 a fever • cough lasts more than 7

days, comes back, or is accompanied by fever, rash, or

persistent headache. These could be signs of aserious

condition.

SPL UNCLASSIFIED SECTION

If pregnant or breast-feeding, ask a health professional

before use.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. In case of overdose, get

medical help or contact a Poison Control Center right

away.

SPL UNCLASSIFIED SECTION

Directions

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

mL =milliliter

Age Dose
Adults & children 12 years and over	10 mL every 4 hours
hildren under 12 years of age	Do not use

SPL UNCLASSIFIED SECTION

Other information

• each 10 mL contains: sodium 3 mg

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

• dosage cup provided

SPL UNCLASSIFIED SECTION

Inactive ingredients

anhydrous citric acid, flavor, purified water, sodium benzoate, sucrose

SPL UNCLASSIFIED SECTION

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Principal Display Panel

CVS

HealthTM

Compare to the active

ingredients in Robitussin® CF *

MAXIMUM STRENGTH

Non-Drowsy

Tussin CF

ADULT COUGH &

COLD

Free of alcohol, dyes &

artificial sweeteners

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN

Expectorant

PHENYLEPHRINE HCl

Nasal decongestant

Relieves:

• Cough

• Stuffy nose

• Chest congestion

For Ages

12 & Over

Cherry Flavor

8 FL OZ (237 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

DO NOT REFRIGERATE. STORE AT ROOM TEMPERATURE.

*This product is not manufactured or distributed by Pfizer,

owner of the registered trademark Robitussin®.

Lot:

Exp:

LR-109 REV 01 #339103

0 50428 61580 5

DRUG FACTS →

CONTINUED

ON BACK

V-34690

√CVS® Quality

Money Back Guarantee

↓Product Package↓

Tussin CF by CVS Pharmacy, Inc.

res

INGREDIENTS AND APPEARANCE

TUSSIN CF

dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76281-311
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	10 mg in 10 mL

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76281-311-26	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	08/01/2018

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Name	Address	ID/FEI	Business Operations
Establishment
AptaPharma Inc.		790523323	manufacture(76281-311)

Revised: 12/2019

Document Id: ca064f73-10bd-4354-9ce7-a1c0b7b01da5

Set id: 0da76857-71ab-433d-9ad9-415ed94ce5ff

Version: 2

Effective Time: 20191209

Search by Drug Name or NDC

NDC 76281-0311-26 Tussin CF 20; 200; 10 mg/10mL; mg/10mL; mg/10mL Details

Tussin CF 20; 200; 10 mg/10mL; mg/10mL; mg/10mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 76281-0311-26 (76281031126)

Contents

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Principal Display Panel

INGREDIENTS AND APPEARANCE

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