Menthol 7.5 Mg

Menthol 7.5 Mg
SPL v7
SPL
SPL Set ID 77f65f59-7ea1-adce-e053-2991aa0a6f1f
Route
ORAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (7.5 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Pill Appearance
Imprint: B Shape: oval Color: yellow Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-11

Description

Active ingredient (in each drop) Menthol 7.5 mg


Medication Information

Warnings and Precautions

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 of doctor promptly. These symptoms may be serious.

Indications and Usage

Uses temporarily relieves:

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

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
Description

Active ingredient (in each drop) Menthol 7.5 mg

Section 50565-1

Keep out of the reach of children.

Section 50566-9

Stop use and 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 serious condition.
  • sore throat is severe, or irritation, pain or redness lasts or worsens
  • sore mouth does not improve in 7 days
Section 50569-3

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)
Section 51727-6

Inactive ingredients: Beta carotene, corn starch, corn syrup, eucalyptus oil, glycerin, honey, medium chain triglycerides, natural and artificial flavors, soybean oil, sucrose and water.

Section 51945-4

Section 53413-1

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

Section 53414-9

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

Section 55105-1

Purpose

Cough suppressant / Oral anesthetic

Section 55106-9

Active ingredient (in each drop)

Menthol 7.5 mg

Section 60561-8

Other information:

  • 10 calories per drop
  • Do not use if bag is torn or open

Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves:

  • cough as may occur with a cold
  • occasional minor irritation and sore throat
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

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 of doctor promptly. These symptoms may be serious.

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 50566-9 (50566-9)

Stop use and 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 serious condition.
  • sore throat is severe, or irritation, pain or redness lasts or worsens
  • sore mouth does not improve in 7 days
Section 50569-3 (50569-3)

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)
Section 51727-6 (51727-6)

Inactive ingredients: Beta carotene, corn starch, corn syrup, eucalyptus oil, glycerin, honey, medium chain triglycerides, natural and artificial flavors, soybean oil, sucrose and water.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough suppressant / Oral anesthetic

Section 55106-9 (55106-9)

Active ingredient (in each drop)

Menthol 7.5 mg

Section 60561-8 (60561-8)

Other information:

  • 10 calories per drop
  • Do not use if bag is torn or open

Advanced Ingredient Data


Raw Label Data

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