counteract cough drops honey lemon content of label

counteract cough drops honey lemon content of label
SPL v7
SPL
SPL Set ID 84ac3489-9d64-401f-ab78-715af4de5440
Route
oral
Published
Effective Date 2011-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (7 mg)
Inactive Ingredients
ascorbic acid .beta.-carotene corn syrup honey sodium ascorbate sucrose tea tree oil

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: oval Color: yellow Size: 22 mm Score: 1
Marketing Status
otc monograph drug active Since 2008-05-20

Description

Active ingredient (in each drop) Menthol 7 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.

Active Ingredient

Active ingredient (in each drop)

Menthol 7 mg

Indications and Usage

Uses temporarily relieves:

■ cough associated with a cold

■ occasional minor irritation or sore throat

Dosage and Administration

Directions

■ adults and children 5 years and over: dissolve 1 drop slowly in the mouth.

Repeat every 2 hours as needed.

■ children under 5 years: ask a doctor

Description

Active ingredient (in each drop) Menthol 7 mg

Section 43683-2

Indications and Usage section verbiage slightly changed FROM:

■ cough associated with a cold or inhaled ingredients ■ occasional minor irritation, pain, sore mouth, and sore throat

TO:

■ cough due to cold ■ occasional minor irritation or sore throat"

Dosage and Administration section changed FROM:

adults and children 5 years and over: dissolve 1 drop slowly in the mouth. May be repeated every hour as needed or as directed by a doctor.

children under 5 years: ask a doctor

TO:

■ adults and children 5 years and over: dissolve 1 drop slowly in the mouth.

Repeat every 2 hours as needed.

■ children under 5 years: ask a doctor

Section 44425-7

Other information

  • 15 calories per lozenge
  • store at room temperature
  • protect from moisture and heat

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if:

■ cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

■ sore mouth does not improve in 7 days

■ irritation, pain, or redness persists or worsens

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

sucrose, corn syrup, honey, natural flavor, beta-carotene, T40-C3 Melaleuca oil, sodium ascorbate, ascorbic acid

Section 51945-4

Section 55105-1

Purpose

Cough suppressant, oral anesthetic


Structured Label Content

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.

Active Ingredient (55106-9)

Active ingredient (in each drop)

Menthol 7 mg

Indications and Usage (34067-9)

Uses temporarily relieves:

■ cough associated with a cold

■ occasional minor irritation or sore throat

Dosage and Administration (34068-7)

Directions

■ adults and children 5 years and over: dissolve 1 drop slowly in the mouth.

Repeat every 2 hours as needed.

■ children under 5 years: ask a doctor

Section 43683-2 (43683-2)

Indications and Usage section verbiage slightly changed FROM:

■ cough associated with a cold or inhaled ingredients ■ occasional minor irritation, pain, sore mouth, and sore throat

TO:

■ cough due to cold ■ occasional minor irritation or sore throat"

Dosage and Administration section changed FROM:

adults and children 5 years and over: dissolve 1 drop slowly in the mouth. May be repeated every hour as needed or as directed by a doctor.

children under 5 years: ask a doctor

TO:

■ adults and children 5 years and over: dissolve 1 drop slowly in the mouth.

Repeat every 2 hours as needed.

■ children under 5 years: ask a doctor

Section 44425-7 (44425-7)

Other information

  • 15 calories per lozenge
  • store at room temperature
  • protect from moisture and heat

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

■ cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

■ sore mouth does not improve in 7 days

■ irritation, pain, or redness persists or worsens

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

sucrose, corn syrup, honey, natural flavor, beta-carotene, T40-C3 Melaleuca oil, sodium ascorbate, ascorbic acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Cough suppressant, oral anesthetic


Advanced Ingredient Data


Raw Label Data

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