sucrets vapor cherry 63736-925-18

sucrets vapor cherry 63736-925-18
SPL v1
SPL
SPL Set ID 471af502-5b3a-4897-b22d-78859b73a217
Route
oral
Published
Effective Date 2024-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dyclonine (3 mg) menthol (6 mg)
Inactive Ingredients
acesulfame potassium ascorbic acid citric acid monohydrate corn syrup fd&c red no. 40 sucrose propylene glycol sodium ascorbate tartaric acid water zinc gluconate

Identifiers & Packaging

Pill Appearance
Imprint: S Shape: oval Color: red Size: 19 mm Score: 1
Marketing Status
otc monograph drug active Since 2009-07-28

Purpose

Oral anesthetic Cough suppressant

Description

Dyclonine hydrochloride 3 mg Menthol 6 mg


Medication Information

Warnings

Sore throat 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.

Uses

For temporary relief of occasional:

  • minor irritation

  • pain

  • sore mouth

  • sore throat
Purpose

Oral anesthetic

Cough suppressant

Directions
  • do not use more than directed

  • adults and children 4 years of age and older: allow lozenge to dissolve slowly in mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor.

  • children under 4 years of age: ask a dentist or doctor
Other Information
  • store between 15-30°C (59-86°F)

  • use only if lozenge blister seals are unbroken
Inactive Ingredients

acesulfame potassium, ascorbic acid, citric acid, corn syrup, fd&c red no. 40, liquid sucrose, propylene glycol, sodium ascorbate, tartaric acid, water, wild cherry flavor, zinc gluconate

Description

Dyclonine hydrochloride 3 mg Menthol 6 mg

Principal Display Panel

SUCRETS 

DYCLONINE / ORAL ANESTHETIC

MENTHOL / COUGH SUPPRESSANT



VAPOR CHERRY

18 LOZENGES

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.

Active Ingredient (per Lozenge)

Dyclonine hydrochloride 3 mg

Menthol 6 mg


Structured Label Content

Warnings

Sore throat 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.

Uses

For temporary relief of occasional:

  • minor irritation

  • pain

  • sore mouth

  • sore throat
Purpose

Oral anesthetic

Cough suppressant

Directions
  • do not use more than directed

  • adults and children 4 years of age and older: allow lozenge to dissolve slowly in mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor.

  • children under 4 years of age: ask a dentist or doctor
Other Information (Other information)
  • store between 15-30°C (59-86°F)

  • use only if lozenge blister seals are unbroken
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, ascorbic acid, citric acid, corn syrup, fd&c red no. 40, liquid sucrose, propylene glycol, sodium ascorbate, tartaric acid, water, wild cherry flavor, zinc gluconate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

SUCRETS 

DYCLONINE / ORAL ANESTHETIC

MENTHOL / COUGH SUPPRESSANT



VAPOR CHERRY

18 LOZENGES

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

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 (1-800-222-1222) right away.

Active Ingredient (per Lozenge) (Active ingredient (per lozenge))

Dyclonine hydrochloride 3 mg

Menthol 6 mg


Advanced Ingredient Data


Raw Label Data

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