TUSNEL C- codeine phosphate, guiafenesin, pseudoephedrine hcl liquid

Tusnel by

Drug Labeling and Warnings

Tusnel by is a Otc medication manufactured, distributed, or labeled by Llorens Pharmaceutical International Division. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients(in each 5 ml tsp.)                                  Purpose

Codeine Phosphate ................................................. 10 mg .......... Cough Suppressant

Guaifenesin .......................................................... 100 mg .................. Expectorant

Pseudoephedrine HCl ............................................. 30 mg .......... Nasal Decongestant

PURPOSE

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily relieves: nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis, cough due to minor bronchial irritation as may occur with the common cold
• temporarily restores freer breathing through the nose
• calms the cough control center and relieves coughing

WARNINGS

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.

When using this product
do nol exceed recommended dosage
may cause or aggravate constipation

DO NOT USE

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) 
• a breathing problem or persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. chronic pulmonary disease or shortness of breath, or who are taking other drugs

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 persistant headache. These could be signs of a serious condition.
  

KEEP OUT OF REACH OF CHILDREN

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION

Directions: Follow dosage chart
Dosage may be repeated every 6 hours. Not to exceed 4 doses in 24-hours. Giving a higher dose
than recommended by a doctor could result in serious side effects for your child. A special measuring
device should be used to give an accurate dose of this product to children under 6 years of age.

Age	Weight	Dose
children 12 years of age and over	95 lbs and up	Take 2 teaspoonfuls (10 mL); every 6 hours
Children 6 to under 12 years of age	45 lbs to under 95 lbs	Take 1 teaspoonful (5mL); every 6 hours
Children under 6 years of age	under 45 lbs	ask a doctor

INDICATIONS & USAGE

Other information

• store at controlled room temperature 20°- 25°C (68°- 77°F)
• Each teaspoonful (5 ml) contains: sodium 2mg
  

• Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.
  

INACTIVE INGREDIENT

Inactive ingredients aspartame, citric acid, glycerine, methylparaben,
natural and artificial flavors, potassium citrate, potassium sorbate,
propylene glycol, propylparaben, purified water.

QUESTIONS

Questions or Comments? 1-866-595-5598

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TUSNEL  C
codeine phosphate, guiafenesin, pseudoephedrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-520
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)	CODEINE PHOSPHATE	10 mg  in 5 mL
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-520-16	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/1995

Labeler - Llorens Pharmaceutical International Division (037342305)

Registrant - Llorens Pharmaceutical International Division (037342305)