Halls Honey Bag

Halls Honey Bag
SPL v3
SPL
SPL Set ID 837f5ded-8efb-402b-a1bc-b5c142755660
Route
ORAL
Published
Effective Date 2019-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.8 mg)
Inactive Ingredients
Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 5 Honey Lecithin, Soybean Sucrose Water

Identifiers & Packaging

Pill Appearance
Imprint: H Shape: oval Color: yellow Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-01-25 Until 2023-08-21

Description

<(per drop) Menthol 1.8 mg>

Purpose

<Cough suppressant, Oral anesthetic>


Medication Information

Purpose

<Cough suppressant, Oral anesthetic>

Description

<(per drop) Menthol 1.8 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 or

followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

These may be serious.>

Directions
  • <adults and children 5 years and over: dissolve 3 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor>
Questions?

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

www.gethalls.com>

Active Ingredient

<(per drop) Menthol 1.8 mg>

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

<FD&C blue 1, FD&C red 40, FD&C yellow 5 (tartrazine), flavors, glucose syrup, honey, 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.

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 or

followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

These may be serious.>

Directions
  • <adults and children 5 years and over: dissolve 3 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor>
Questions?

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

www.gethalls.com>

Active Ingredient

<(per drop) Menthol 1.8 mg>

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

<FD&C blue 1, FD&C red 40, FD&C yellow 5 (tartrazine), flavors, glucose syrup, honey, 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.)

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

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