TUSSIN CF- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

TUSSIN CF by

Drug Labeling and Warnings

TUSSIN CF by is a Otc medication manufactured, distributed, or labeled by Consumer Value Products, Inc., AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL tsp)
Dextromethorphan HBr, USP    10 mg
Guaifenesin, USP                  100 mg
Phenylephrine HCI, USP            5 mg

PURPOSE

Purpose
Dextromethorphan HBr...........................Cough Suppressant
Guaifenesin ..........................................Expectorant
Phenylephrine HCl .................................Nasal Decongestant

INDICATIONS & USAGE

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

Warnings
Do not use ■ if you are now taking aprescription 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 DOCTOR

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/PHARMACIST

Ask a doctor or pharmacist before use if you are taking any other oral nasal
decongestant or stimulant.

STOP USE

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, or is accompanied
by fever, rash or persistent headache.
These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask ahealth professilfial before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose,
get medical help or contact a Poison Control Center
right away.

DOSAGE & ADMINISTRATION

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.

             Age                                              Dose
adults & children 12 years & over     2 teaspoons every 4 hours
children under 12 years                      do not use

OTHER SAFETY INFORMATION

Other information
■Keep carton for full Directions for use.
■ store at 20-25°C (68-77°F)
■ do not refrigerate
■ dosage cup provided
■ sodium 3 mg per teaspoonful

INACTIVE INGREDIENT

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

QUESTIONS

Questions? Call weekdays from 9:30 AM to 4:30

PM EST at 1-877-798-5944

Principal Display Panel

               CVP®
             HEALTH

            TUSSIN
                CF

COUGH & CHEST CONGESTION

          NON-DROWSY

   COUGH SUPPRESSANT

         EXPECTORANT

  NASAL DECONGESTANT

     COMPARE TO THE ACTIVE INGREDIENTS IN
ROBITUSSIN® PEAK COLD MULTI-SYMPTOM COLD®

               CVP®
            HEALTH

           TUSSIN
               CF

       COUGH & CHEST
         CONGESTION

 DEXTROMETHORPHAN HBr/
GUAIFENESIN/PHENYLEPHRINE HCl

            NON-DROWSY
      COUGH SUPPRESSANT
           EXPECTORANT
    NASAL DECONGESTANT

RELIEVES

• COUGH
• MUCUS
• NASAL CONGESTION

FOR AGES 12 AND OVER

4 FL OZ (118 mL)

DO NOT USE IF PRINTED SEAL UNDER
      CAP IS TORN OR MISSING

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

DISTRIBUTED BY
CONSUMER VALUE PRODUCTS, INC.
P.O. BOX 6115 TEMPLE, TX 76502
CVPproducts.com

7   61706 16125   8

                                   BX-074

↓ Bottle Label ↓

     TUSSIN CF by Consumer Value Products, Inc.  

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INGREDIENTS AND APPEARANCE

TUSSIN CF 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57243-504
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	red	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57243-504-24	1 in 1 CARTON	10/01/2018
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2018

Labeler - Consumer Value Products, Inc. (009830555)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(57243-504)