Ynby-mgc Bc Sf 25-70 2023

Ynby-mgc Bc Sf 25-70 2023
SPL v2
SPL
SPL Set ID 29f3ddcc-9d4e-f1b1-e063-6294a90ac86f
Route
ORAL
Published
Effective Date 2022-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5.8 mg)
Inactive Ingredients
Acesulfame Potassium Eucalyptus Oil Fd&c Red No. 40 Isomalt Fd&c Blue No. 1 Lecithin, Soybean Water Aspartame

Identifiers & Packaging

Pill Appearance
Imprint: B Shape: oval Color: red Size: 21 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-01

Description

Menthol 5.8

Purpose

Purposes cough suppressant, oral anesthetic


Medication Information

Purpose

Purposes cough suppressant, oral anesthetic

Description

Menthol 5.8

Use

temporary relieves: ■ cough due to cold ■ occasional minor irritation or sore throat

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 accompained by fever, rash, or persistent headache. These could be signs of a serius 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 53413-1

Call Toll-Free 866-306-9136 or visit our website: www.mgc.us

[email protected]

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.

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.

Other Information

phenylketonurics: contains phenylalanine 2 mg per drop

excessive consumption may have a laxative effect

contains: SOY.

-5 calories per drop

Active Ingredient(s)

Menthol 5.8

Inactive Ingredients

Acesulfame potassium, aspartame, eucalyptus oil, maltitol, FD&C blue 1. FD&C red 40, flavors. isomalt, soy lecithin, sucralose, water.

Package Label Principal Display Panel

25 Drops NDC: 61658-127-25


Structured Label Content

Use

temporary relieves: ■ cough due to cold ■ occasional minor irritation or sore throat

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 accompained by fever, rash, or persistent headache. These could be signs of a serius 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 53413-1 (53413-1)

Call Toll-Free 866-306-9136 or visit our website: www.mgc.us

[email protected]

Purpose

Purposes cough suppressant, oral anesthetic

Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious.

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.

Other Information (Other information)

phenylketonurics: contains phenylalanine 2 mg per drop

excessive consumption may have a laxative effect

contains: SOY.

-5 calories per drop

Active Ingredient(s)

Menthol 5.8

Inactive Ingredients (Inactive ingredients)

Acesulfame potassium, aspartame, eucalyptus oil, maltitol, FD&C blue 1. FD&C red 40, flavors. isomalt, soy lecithin, sucralose, water.

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

25 Drops NDC: 61658-127-25


Advanced Ingredient Data


Raw Label Data

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