Tusslin
FDA Label NDC 52083-622

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Tusslin (NDC 52083-622). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purposes, uses, do not use if, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

(in each 5 mL teaspoonful) 

 Dextromethorphan HBr, 28 mg

Guaifenesin, 388 mg

Phenylephrine HCl, 10 mg

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

Uses

  • suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tunes, and make cough more productive
  • temporarily relieves nasal congestion due to a cold

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

  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

When Using This Product

do not use more than directed.

Stop Use And Ask A Doctor If

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanies by fever
  • cough lasts for more than 7 days, comes back, or is accompanied by fever, rash persistent headache. These can 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 accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • do not take more than 4 doses in any 24-hour period
  • EVERY 6 HOURS
    • Adults and children 12 years of age and over5 mL (1 tsp.)
    Children 6 to under 12 years of age2.5 mL (1/2 tsp.)
    Children 2 to 6 years of age1.25 mL (1/4 tsp.)
    Children under 2 years of ageconsult physician

Other Information

  • Tamper evident: Do not use if safety seal is broken or missing
  • Store at controlled room temperature, between 15°-30°C (59°-86°F)

Inactive Ingredients

Citric Acid, Flavor, Glycerin, Methyl Paraben, Propyl Paraben, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Water.

Package/Label Principal Display Panel

NDC 52083-622-16

TUSSLIN®

COUGH SUPPRESSANT

EXPECTORANT AND

NASAL DECONGESTANT

Contains the same active ingredients as Giltuss

SUGAR FREE

ALCOHOL FREE

GRAPE FLAVOR

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