Counteract Cough Drops Orchard Cherry Content Of Label

Counteract Cough Drops Orchard Cherry Content Of Label
SPL v7
SPL
SPL Set ID 6049842c-d763-4a91-a225-976ed74e1693
Route
ORAL
Published
Effective Date 2011-03-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (7 mg)
Inactive Ingredients
Corn Syrup Sodium Ascorbate Ascorbic Acid Sucrose Tea Tree Oil Cherry Annatto

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: oval Color: red 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.

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 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, natural flavor, annatto extract, T40-C3 Melaleuca oil, sodium ascorbate, ascorbic acid

Section 51945-4

Section 55105-1

Purpose

Cough suppressant, oral anesthetic

Section 55106-9

Active ingredient

(in each drop)


Menthol 7 mg



Section 60561-8

Other information

15 calories per drop

store at room temperature

protect from moisture and heat


Structured Label Content

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

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.

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 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, natural flavor, annatto extract, T40-C3 Melaleuca oil, sodium ascorbate, ascorbic acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Cough suppressant, oral anesthetic

Section 55106-9 (55106-9)

Active ingredient

(in each drop)


Menthol 7 mg



Section 60561-8 (60561-8)

Other information

15 calories per drop

store at room temperature

protect from moisture and heat


Advanced Ingredient Data


Raw Label Data

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