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 AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

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

PURPOSE

Purpose
Dextromethorphan HBr USP ........Cough Suppressant
Guailenesin USP ..........................Expectorant
Phenylephrine HCI, USP ...............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, psychialric or emotional conditions or
Parkinson's disease), or for 2 weeks aMer stopping
the MAOI drug. If you do not know il 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 il you are
taking any other oral nasal decongestant or stimulant.

WHEN USING

When using this product do not use more than
directed.

STOP USE

Stop use and ask a doctor if
■ you get nervous, diuy 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 ot aserious
   condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose,
get medical help or contact aPoison 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: 2 teaspoons every 4 hours

OTHER SAFETY INFORMATION

Other information
■ Keep carton for full Direction for use
■ store at 20-25ºC (68-77ºF)
■ do not refrigerate
■ dosage cup provided
■ sodium 3 mg per teaspoonful

INACTIVE INGREDIENT

Inactive ingredients
anhydrous 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

Product Label

AP SAFE                         NDC: 76821-504-24

COMPARE TO THE ACTIVE

INGREDIENT IN ROBITUSSIN®

PEAK COLD

MULTI-SYMPTOM COLD*

Adult Tussin

Multi-Symptom Cold

Dextromethorphan HBr / Guaifensesin /

Phenylephrine HCL

Cough Supressant / Expectorant /

Nasal Decongestant

Non-Drowsy

Relieves:
Cough
Mucus
Nasal Congestion
For Ages 12 and over

4 FL OZ (118 mL)

CF

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

5
1013430
3/20

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

Manufactured by:
AptaPharma Inc.,
1533 Union Ave,
Pennsauken, NJ 08110

Ap·BX·05

Carton

Bottle

res

INGREDIENTS AND APPEARANCE

TUSSIN CF 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-504
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 HYDROCHLORIDE	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 SOLUTION (UNII: 8KW3E207O2)
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: 76281-504-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/30/2020

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-504)