Sucrets Lozenge
FDA Label NDC 63736-567

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Sucrets (NDC 63736-567). 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 otc - active ingredient, otc - purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients (per lozenge)

Otc - Purpose

Active ingredients (per lozenge)Purpose
 Dyclonine hydrochloride, 2 mg Oral anesthetic/Analgesic
 Menthol, 5 mg Cough suppressant
 Pectin, 6 mg Demulcent

Uses

Temporarily relieves:

  • occasional minor irritation, pain, sore throat, and sore mouth
  • cough associated with a cold or inhaled irritants
  • for protection of irritated areas in sore mouth and throat

Warnings

Sore through warning: if sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Ask A Doctor Before Use If You Have

  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • cough that occurs with too mych phlegm (mucus)

Stop Use And Ask A Doctor If

  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash, or fever develops
  • cough lasts more than 7 days, comes back, or occurs with fever, 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 (1-800-222-1222) right away.

Directions

  • Do not use more than directed
  • adults and children 4 years of age and older: Dissolve 1 lozenge slowly in the mouth. May be repeated every 2 hours as needed or as directed by a doctor or dentist
  • children under 4 years of age: consult a doctor or dentist

Other Information

  • store between 15°-30°C (59°-86°F)
  • use only if lozenge blister seals are unbroken
  • contains FD&C Yellow No.5 (tartrazine) as a color additive

Inactive Ingredients

corn syrup, FD&C yellow no.5, FD&C yellow no.6, honey, lemon oil, propylene glycol, sucrose, tartaric acid, water

Questions

1-800-344-7239

Sucrets.com

Principal Display Panel

Sucrets Sore Throat, Cough & Dry Mouth

Dyclonine/Oral Anesthetic

Menthol/Cough Suppressant

Pectin/Dry Mouth

18 lozenges

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