Freegells Cough Drops Menthol Strawberry

Freegells Cough Drops Menthol Strawberry
SPL v2
SPL
SPL Set ID da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457
Route
ORAL
Published
Effective Date 2022-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.7 mg)
Inactive Ingredients
Citric Acid Monohydrate Corn Syrup Eucalyptus Oil Fd&c Red No. 40 Sucrose Water

Identifiers & Packaging

Pill Appearance
Shape: oval Color: pink Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-01

Description

Menthol 2.7 mg

Purpose

Cough suppressant/ Oral anesthetic


Medication Information

Purpose

Cough suppressant/ Oral anesthetic

Description

Menthol 2.7 mg

Uses

temporarily relieves:

  • cough as may occur with a cold
  • occasional minor irritation and sore throat
Warnings

if sore throat is severe, persists for more than 2 days, is accompained or follwed 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 promtly. These symptoms may be serious. Sore throat warning:

Directions
 adults and children 5 years and over

 dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.

 children under 5 years   ask a doctor 

Drug Facts

Other Information
  • 11 calories per drop
  • do not use if bags is torn or open
  • Contains: Soy.
Inactive Ingredients:

citric acid, corn syrup, eucalyptus oil, FD&C red no.40, natural & artificial flavoring, soy lecithin, sucrose and water.

Stop Use Ask Doctor If
  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serius condition.
  • sore throat is severe, or irritation, pain o redness lasts or worsens
  • sore mouth does not improve in 7 days
Package Labeling:71165 014 00

Active Ingredient (in Each Drop)

Menthol 2.7 mg

If Pregnant Or Breast Feeding, 

ask a health professional before use.

Ask A Doctor Before Use If You Have:
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompained by excessive phlegm (mucus)

Structured Label Content

Uses

temporarily relieves:

  • cough as may occur with a cold
  • occasional minor irritation and sore throat
Purpose

Cough suppressant/ Oral anesthetic

Warnings

if sore throat is severe, persists for more than 2 days, is accompained or follwed 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 promtly. These symptoms may be serious. Sore throat warning:

Directions
 adults and children 5 years and over

 dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.

 children under 5 years   ask a doctor 

Drug Facts

Other Information (Other information)
  • 11 calories per drop
  • do not use if bags is torn or open
  • Contains: Soy.
Inactive Ingredients: (Inactive ingredients:)

citric acid, corn syrup, eucalyptus oil, FD&C red no.40, natural & artificial flavoring, soy lecithin, sucrose and water.

Stop Use Ask Doctor If (Stop use ask doctor if)
  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serius condition.
  • sore throat is severe, or irritation, pain o redness lasts or worsens
  • sore mouth does not improve in 7 days
Package Labeling:71165 014 00 (Package Labeling:71165-014-00)

Active Ingredient (in Each Drop) (Active ingredient (in each drop))

Menthol 2.7 mg

If Pregnant Or Breast Feeding,  (If pregnant or breast-feeding, )

ask a health professional before use.

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompained by excessive phlegm (mucus)

Advanced Ingredient Data


Raw Label Data

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