TUSSIN CF- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid

Tussin CF by

Drug Labeling and Warnings

Tussin CF by is a Otc medication manufactured, distributed, or labeled by davAgen Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each 5 mL tsp):	Purpose
Dextromethorphan HBr, USP 10 mg	Cough suppressant
Guaifenesin, USP 100 mg	Expectorant
Phenylephrine HCl, USP 5 mg	Nasal decongestant

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

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.

Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema, trouble urinating due to an enlarged prostate gland

Do not exceed recommended dose

Stop use and ask a doctor if 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, ask a health professional before use.

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

Other information

Each tsp contains: sodium 6 mg. Store at 20°-25°C (68°-77°F), Do not refrigerate.

Dosage cup provided.

Inactive ingredients

citric acid, FD & C Red # 40, flavor, glycerin, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Directions

do not take more than 6 doses in any 24-hour period

• this adult product is not intended for use in children under 12 years of age
• mL = milliliter; tsp = teaspoonful

age	dose
adults and children 12 years and over	10 mL (2 tsp) every 4 hours
children under 12 years	do not use

SPL UNCLASSIFIED SECTION

Manufactured by:
davAgen
Pharmaceutical LLC
Somerset, NJ 08873

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

davAgen
pharmaceutical

NDC: 76140-105-08

Adults & Children Ages 12 & Older

Tussin CF

Cough & Cold

Cough Suppressant - Dextromethorphan HBr
Expectorant - Guaifenesin
Nasal Decongestant - Phenylephrine HCl

For Relief of:

• Stuffy Nose
• Cough
• Chest Congestion & Mucus

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

TUSSIN CF 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76140-105
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
Sodium Benzoate (UNII: OJ245FE5EU)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sorbitol (UNII: 506T60A25R)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sucralose (UNII: 96K6UQ3ZD4)
FD&C Red NO. 40 (UNII: WZB9127XOA)
Propylene Glycol (UNII: 6DC9Q167V3)
Glycerin (UNII: PDC6A3C0OX)
Sodium Citrate (UNII: 1Q73Q2JULR)
Menthol (UNII: L7T10EIP3A)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY, FRUIT, MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76140-105-08	1 in 1 CARTON
1		236 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	04/10/2013

Labeler - davAgen Pharmaceutical, LLC (967545935)

Establishment
Name	Address	ID/FEI	Business Operations
davAgen Pharmaceutical, LLC		967545935	MANUFACTURE(76140-105) , PACK(76140-105) , LABEL(76140-105) , ANALYSIS(76140-105)