Quality Choice Honey Lemon Sugar Free Cough Drops

Quality Choice Honey Lemon Sugar Free Cough Drops
SPL v3
SPL
SPL Set ID 1fd0a790-c67c-216f-e063-6294a90ae971
Route
ORAL
Published
Effective Date 2024-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (7.6 mg)
Inactive Ingredients
Beta Carotene Isomalt Maltitol Eucalyptus Oil Sucralose Lecithin, Soybean Water

Identifiers & Packaging

Pill Appearance
Shape: oval Color: yellow Size: 21 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-15

Description

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.

Purpose

Purposes cough suppressant, oral anesthetic


Medication Information

Purpose

Purposes cough suppressant, oral anesthetic

Description

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.

Use

temporary relieves: ■ cough due to cold ■ occasional minor irritation, pain, sore mouth, and sore throat

Section 43683-2

[Indications and Usage Section]: Minor editing was done to comply with monograph wording of uses. Changes were made Nov 2024.

[Dosage and Administration Section]: Minor editing was done to improve section clarity. No changes were made to dosage or administration. Changes were made Nov 2024.

Section 50565-1

Keep this and all drugs 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 accompained by fever, rash, or persistent headache. A persistant cough may be a sign of a serius condition. ■ sore mouth symptoms do 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 53413-1

Call +1800-935-2362

You may also report concerns to this phone number

Monday to Friday, 9AM - 5PM ET

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.

Directions

■ adults and children 5 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor

■ children under 2 years of age: ask a doctor

Other Information

■ store at room temperature

■ keep away from excessive heat or sunlight

■ do not use if primary bag seal has been torn or broken

■ contains: SOY

Active Ingredient(s)

Menthol 7.6 mg

Inactive Ingredients

Beta carotene, eucalyptus oil, isomalt, lemon flavor, maltitol, soy lecithin, sucralose, water

Package Label Principal Display Panel

25 Drops NDC: 83324-288-25


Structured Label Content

Use

temporary relieves: ■ cough due to cold ■ occasional minor irritation, pain, sore mouth, and sore throat

Section 43683-2 (43683-2)

[Indications and Usage Section]: Minor editing was done to comply with monograph wording of uses. Changes were made Nov 2024.

[Dosage and Administration Section]: Minor editing was done to improve section clarity. No changes were made to dosage or administration. Changes were made Nov 2024.

Section 50565-1 (50565-1)

Keep this and all drugs 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 accompained by fever, rash, or persistent headache. A persistant cough may be a sign of a serius condition. ■ sore mouth symptoms do 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 53413-1 (53413-1)

Call +1800-935-2362

You may also report concerns to this phone number

Monday to Friday, 9AM - 5PM ET

Purpose

Purposes cough suppressant, oral anesthetic

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.

Directions

■ adults and children 5 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor

■ children under 2 years of age: ask a doctor

Other Information (Other information)

■ store at room temperature

■ keep away from excessive heat or sunlight

■ do not use if primary bag seal has been torn or broken

■ contains: SOY

Active Ingredient(s)

Menthol 7.6 mg

Inactive Ingredients (Inactive ingredients)

Beta carotene, eucalyptus oil, isomalt, lemon flavor, maltitol, soy lecithin, sucralose, water

Package Label Principal Display Panel (Package Label - Principal Display Panel)

25 Drops NDC: 83324-288-25


Advanced Ingredient Data


Raw Label Data

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