SUGAR FREE MENTHOL COUGH DROPS

Main information

  • Trade name:
  • SUGAR FREE MENTHOL COUGH DROPS- menthol lozenge
  • Composition:
  • MENTHOL 5.8 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SUGAR FREE MENTHOL COUGH DROPS- menthol lozenge
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Purpose Cough suppressant / Oral anesthetic Uses temporarily relieves: cough as may occur with a cold occasional minor irritation and sore throat Stop use and consult doctor if cough persists for more than 7 days, tends to recur, or is acconpanied by fever, rash, or persistent headache. These could be signs of a serious condition. sore throat is severe, or irritation, pain or redness lasts or worsens sore mouth does not improve in 7 days

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 41250-157-25
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

SUGAR FREE MENTHOL COUGH DROPS- menthol lozenge

Meijer

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Menthol 5.8 mg

Active ingredient (in each drop)

Menthol 5.8 mg

Purpose

Cough suppressant / Oral anesthetic

Uses temporarily relieves:

cough as may occur with a cold

occasional minor irritation and sore throat

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed

by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth

symptoms do not improve in 7 days, see your dentist or doctor promptly. These symptoms may be

serious.

Ask a doctor before use if you have:

persistent or chronic cough such as occurs with smoking, asthma, or emphysema

cough accompanied by excessive phlegm (mucus)

Stop use and consult doctor if

cough persists for more than 7 days, tends to recur, or is acconpanied by fever, rash, or persistent

headache. These could be signs of a serious condition.

sore throat is severe, or irritation, pain or redness lasts or worsens

sore mouth does not improve in 7 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions

adults and children 5 years and over - dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as

needed or a directed by a doctor.

children under 5 years - ask a doctor

Other information

6 calories per drop

Excess consumption may cause a laxative effect.

Inactive ingredients: acesulfame potassium (non-nutritive sweetener), corn starch, eucalyptus oil, FD&C

blue no. 1, FD&C red no. 40, glycerin, gum arabic, isomalt, maltitol syrup, medium chain triglycerides,

natural and artificial flavors, potassium sorbate, soybean oil, sucralose (non-nutritive sweetener), and

water.

Questions? Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST

SUGAR FREE MENTHOL COUGH DROPS

menthol lozenge

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:41250 -157

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

5.8 mg

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

blue (light blue with blue flakes)

S core

no sco re

S hap e

OVAL

S iz e

17mm

Flavor

MENTHOL

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:41250 -157-25

25 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

10 /18 /20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

10 /18 /20 17

Labeler -

Meijer (006959555)

Registrant -

Bestco Inc. (002149136)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Me ije r

Bestco Inc.

0 0 2149 136

ma nufa c ture (41250 -157)

Revised: 10/2017