quality choice ®

quality choice ®
SPL v2
SPL
SPL Set ID 230883da-de48-68e9-e063-6394a90a927c
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

Purpose

cough suppressant, oral anesthetic

Description

Menthol 5.8 mg


Medication Information

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.

Uses

temporarily relieves:

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

Purpose

cough suppressant, oral anesthetic

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

• 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.

Description

Menthol 5.8 mg

Questions?

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

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

Packaging

Drug Facts

Active Ingredient (per Drop)

Menthol 5.8 mg


Structured Label Content

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.

Uses

temporarily relieves:

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

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)

• 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.

Questions?

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

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

Packaging

Drug Facts (DRUG FACTS)

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

Menthol 5.8 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)