Label: TUSNEL C- codeine phosphate, guiafenesin, pseudoephedrine hcl liquid
- NDC Code(s): 54859-520-16
- Packager: Llorens Pharmaceutical International Division
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 23, 2020
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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
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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
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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
- 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
- PREGNANCY OR BREAST FEEDING
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DOSAGE & ADMINISTRATION
Directions: Follow dosage chartDosage 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 hoursChildren 6 to under 12 years of age 45 lbs to under 95 lbs Take 1 teaspoonful (5mL)
every 6 hoursChildren under 6 years of age under 45 lbs ask a doctor - INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TUSNEL C
codeine phosphate, guiafenesin, pseudoephedrine hcl liquidProduct 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; Type 0: Not a Combination Product 01/01/1995 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)
