Halls Mentholyptus Bag

Halls Mentholyptus Bag
SPL v10
SPL
SPL Set ID ff21cf0e-9811-4819-bdfc-17a950e9b114
Route
ORAL
Published
Effective Date 2019-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5.4 mg)
Inactive Ingredients
Anhydrous Citric Acid Eucalyptus Oil Fd&c Blue No. 1 Fd&c Red No. 40 Potassium Citrate Lecithin, Soybean Sucrose Corn Syrup Water

Identifiers & Packaging

Pill Appearance
Imprint: H Shape: oval Color: blue Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-07 Until 2020-04-21

Description

<(per drop) Menthol 5.4 mg>

Purpose

<Cough Suppressant, Oral Anesthetic>


Medication Information

Purpose

<Cough Suppressant, Oral Anesthetic>

Description

<(per drop) Menthol 5.4 mg>

Uses

<temporarily relieves:>

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

<Cough Suppressant, Oral Anesthetic>

Warnings

< Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, swelling, or vomiting, consult a doctor promptly. These may be serious.>

Questions

<Call 1-800-524-2854, Monday to Friday, 9AM-6PM Eastern Time or visit our website at www.gethalls.com>

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

Active Ingredient

<(per drop) Menthol 5.4 mg>

Other Information
  • 10 calories per drop
  • Contains: SOY.
Inactive Ingredients

<citric acid, eucalyptus oil, FDC blue 1, FDC red 40, flavors, glucose syrup, potassium citrate, soy lecithin, sucrose, water>

Otc Principal Display Panel

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

Keep Out of Reach of Children

Enter section text here

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)


Structured Label Content

Uses

<temporarily relieves:>

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

<Cough Suppressant, Oral Anesthetic>

Warnings

< Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied by fever, headache, rash, swelling, or vomiting, consult a doctor promptly. These may be serious.>

Questions

<Call 1-800-524-2854, Monday to Friday, 9AM-6PM Eastern Time or visit our website at www.gethalls.com>

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

Active Ingredient

<(per drop) Menthol 5.4 mg>

Other Information (Other information)
  • 10 calories per drop
  • Contains: SOY.
Inactive Ingredients (Inactive ingredients)

<citric acid, eucalyptus oil, FDC blue 1, FDC red 40, flavors, glucose syrup, potassium citrate, soy lecithin, sucrose, water>

Otc Principal Display Panel (OTC Principal Display Panel)

Stop Use and Ask A Doctor If (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

Keep Out of Reach of Children (Keep out of reach of children)

Enter section text here

Ask A Doctor Before Use If You Have (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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)