Menthol 7.5 Mg

Menthol 7.5 Mg
SPL v1
SPL
SPL Set ID 39e4c956-02e3-049e-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2013-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (7.5 1)
Inactive Ingredients
Water

Identifiers & Packaging

Pill Appearance
Imprint: B Shape: oval Color: yellow Size: 17 mm
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-05-15

Description

Active ingredient (in each drop) Menthol 7.5mg


Medication Information

Warnings and Precautions

Sore throat warning: if sore throat is severs, persists for

more than 2 days, is accompanied or followed by fever,

headaches, rash, swelling, nausea, or vomiting, consult a

doctor promptly. If sore mouth symptoms do not improve

ub 7 days, see your dentist or 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 7.5mg

Section 50565-1

Keep out of reach of children.

Section 50569-3

Ask a doctor before use if you have:

  • persistent or chronic chough such as occurs with

smoking, asthma, or emphysema

  • cough accompanied by excessive phlegm (mucus)
Section 51727-6

Inactive ingredients: Beta carotene (color), conr

starch, corn syrup, eucalyptus oil, glycerin, honey, medium

chain triglycerides, natural & artificial flavors, soybean

oil, sucrose and water

Section 51945-4

Section 53413-1

Questions? Call (888) 309-9030.

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 7.5mg

Section 60561-8

Other Information 10 calories per drop


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)

Sore throat warning: if sore throat is severs, persists for

more than 2 days, is accompanied or followed by fever,

headaches, rash, swelling, nausea, or vomiting, consult a

doctor promptly. If sore mouth symptoms do not improve

ub 7 days, see your dentist or doctor promptly. These

symptoms may be serious.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50569-3 (50569-3)

Ask a doctor before use if you have:

  • persistent or chronic chough such as occurs with

smoking, asthma, or emphysema

  • cough accompanied by excessive phlegm (mucus)
Section 51727-6 (51727-6)

Inactive ingredients: Beta carotene (color), conr

starch, corn syrup, eucalyptus oil, glycerin, honey, medium

chain triglycerides, natural & artificial flavors, soybean

oil, sucrose and water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call (888) 309-9030.

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 7.5mg

Section 60561-8 (60561-8)

Other Information 10 calories per drop


Advanced Ingredient Data


Raw Label Data

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