Sorbugen Syrup
FDA Label NDC 52083-660

11 label sections · Submitted to the FDA by Kramer Novis · 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 Sorbugen (NDC 52083-660). 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 drug facts, active ingredients (in each 7.5 ml, 1 ½ teaspoon), purposes, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients (In Each 7.5 Ml, 1 ½ Teaspoon)

Dextromethorphan HBr, 15 mg
Guaifenesin (Glyceryl Guaiacolate), 150mg

Purposes

Antitussive
Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes, and make coughs more productive

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) 
• 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
• 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.

Otc - Keep Out Of Reach Of Children

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

Directions

 • do not take more than 6 doses in any 24-hour period.
 • mL = milliliter
 • tsp = teaspoon

 age dose
 Adults and children 12 years
of age and over		 2 teaspoonfuls (10 mL)
every 4 hours
 Children under 12 years of age Consult a physician

Other Information

  • Tamper evident feature: Do not use if printed security seal is torn, broken or missing.
  • Store at controlled room temperature 15-30°C (59-86°F).
  • Avoid excessive heat or humidity.

Inactive Ingredients

Citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol, sucralose.

Questions Or Comments?

1-787-767-2072 You may also report serious side effects to this phone number. Call weekdays from 8AM to 4PM AST

Packaging

Sorbugen (52083660 1)

Sorbugen (52083660 1)

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