FDA Label for Sucrets

View Indications, Usage & Precautions

Sucrets Product Label

The following document was submitted to the FDA by the labeler of this product Insight Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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