Quality Choice ®

Quality Choice ®
SPL v4
SPL
SPL Set ID 8f6ee01c-baad-489f-b2fd-0ef506916ee4
Route
ORAL
Published
Effective Date 2024-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: oval Color: red Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-14

Description

Menthol 5.8 mg

Purpose

cough suppressant, oral anesthetic


Medication Information

Purpose

cough suppressant, oral anesthetic

Description

Menthol 5.8 mg

Uses

temporarily relieves:

• cough due to cold • occasional minor irritation or sore throat

Section 42229-5

RESEALABLE BAG

Compare to Active Ingredient of Halls®

Relieves Coughs & Soothes Sore Throats

Soothing Drops,

Starts Working In Seconds

Temporarily Relieves Cough

CLOSE BAG TO MAINTAIN FRESHNESS

CHOKING WARNING:

NOT FOR CHILDREN UNDER 4.

QC 100% SATISFACTION GUARANTEED ®

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Made In China

Section 50565-1

Keep out of reach of children.

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.

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).

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.

Packaging

Drug Facts

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.

Questions?

Call 800 935 2362 Monday-Friday 9AM-5PM EST

Other Information

• 5 calories per drop • contains: SOY.• phenylketonurics: contains phenylalanine 2 mg per drop • excessive consumption may have a laxative effect.

Inactive Ingredients

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

Active Ingredient (per Drop)

Menthol 5.8 mg


Structured Label Content

Uses

temporarily relieves:

• cough due to cold • occasional minor irritation or sore throat

Section 42229-5 (42229-5)

RESEALABLE BAG

Compare to Active Ingredient of Halls®

Relieves Coughs & Soothes Sore Throats

Soothing Drops,

Starts Working In Seconds

Temporarily Relieves Cough

CLOSE BAG TO MAINTAIN FRESHNESS

CHOKING WARNING:

NOT FOR CHILDREN UNDER 4.

QC 100% SATISFACTION GUARANTEED ®

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Made In China

Section 50565-1 (50565-1)

Keep out of reach of children.

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.

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).

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.

Packaging

Drug Facts (DRUG FACTS)

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.

Questions?

Call 800 935 2362 Monday-Friday 9AM-5PM EST

Other Information (Other information)

• 5 calories per drop • contains: SOY.• phenylketonurics: contains phenylalanine 2 mg per drop • excessive consumption may have a laxative effect.

Inactive Ingredients (Inactive ingredients)

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

Active Ingredient (per Drop) (Active ingredient (per drop))

Menthol 5.8 mg


Advanced Ingredient Data


Raw Label Data

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