Green Guard Honey Lemon Cough Drop

Green Guard Honey Lemon Cough Drop
SPL v9
SPL
SPL Set ID 8a94f090-61d6-4909-e053-2995a90aee38
Route
ORAL
Published
Effective Date 2022-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (8.6 mg)
Inactive Ingredients
Food Yellow 3 Free Acid Eucalyptus Oil Honey Lemon Oil Sucrose D&c Yellow No. 10 Corn Syrup

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: oval Color: yellow Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-01

Description

Drug Facts


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, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.

Indications and Usage

Uses

Temporarily relieves

■ cough as may occur with a cold or inhaled irritants

■ occasional minor irritation and sore throat

Dosage and Administration

Directions

■ do not use more than directed

Adults and children: (12 years and older)

Allow 1 drop to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor.

Children under 12 years:

Ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep this and all drugs out of the 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 corn syrup, eucalyptus oil, D&C yellow #10, FD&C yellow #6, honey, lemon oil, sucrose

Section 53413-1

Questions or comments? 1-800-869-6970

Section 53414-9

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

Section 55105-1

Purpose

Antitussive (cough suppressant)/oral anesthetic

Section 55106-9

Active ingredient (in each drop)

Menthol 8.6 mg

Section 60561-8

Other information

■ 15 calories per drop

■ store at 59º-86ºF (15º-30ºC)

■ protect from moisture & heat

Green Guard Honey Lemon Cough Drop Label

Green Guard®

Honey Lemon

Cough Drop relief

Pull to Open

Tire Para Abrir

Menthol 8.6mg/Mentol 8.6mg

Cough Supressant/ Anesthetic

Suprime la tos/ anestesico

Pastillas par la tos

sabor miel y limon

Distributed by Green Guard®, St. Louis, MO 63045

50 Drops

Order #2243


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves

■ cough as may occur with a cold or inhaled irritants

■ occasional minor irritation and sore throat

Dosage and Administration (34068-7)

Directions

■ do not use more than directed

Adults and children: (12 years and older)

Allow 1 drop to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor.

Children under 12 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, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep this and all drugs out of the 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 corn syrup, eucalyptus oil, D&C yellow #10, FD&C yellow #6, honey, lemon oil, sucrose

Section 53413-1 (53413-1)

Questions or comments? 1-800-869-6970

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antitussive (cough suppressant)/oral anesthetic

Section 55106-9 (55106-9)

Active ingredient (in each drop)

Menthol 8.6 mg

Section 60561-8 (60561-8)

Other information

■ 15 calories per drop

■ store at 59º-86ºF (15º-30ºC)

■ protect from moisture & heat

Green Guard Honey Lemon Cough Drop Label

Green Guard®

Honey Lemon

Cough Drop relief

Pull to Open

Tire Para Abrir

Menthol 8.6mg/Mentol 8.6mg

Cough Supressant/ Anesthetic

Suprime la tos/ anestesico

Pastillas par la tos

sabor miel y limon

Distributed by Green Guard®, St. Louis, MO 63045

50 Drops

Order #2243


Advanced Ingredient Data


Raw Label Data

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