halls sugar free black cherry bag

halls sugar free black cherry bag
SPL v9
SPL
SPL Set ID bd2a311a-bf0c-4365-af9b-76675c243b22
Route
oral
Published
Effective Date 2019-06-10
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 fd&c blue no. 1 fd&c red no. 40 isomalt lecithin, soybean water

Identifiers & Packaging

Pill Appearance
Imprint: H Shape: oval Color: red Size: 21 mm Score: 1
Marketing Status
otc monograph drug completed Since 2019-06-10 Until 2022-06-21

Purpose

<Cough Suppressant, Oral Anesthetic>

Description

<(per drop) Menthol 5.8 mg>


Medication Information

Warnings

<Sore throat warning: if sore throat is severe, persist 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.>

Uses

<temporarily relieves:

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

&lt;Cough Suppressant, Oral Anesthetic&gt;

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
  • 5 calories per drop
  • contains soy



Inactive Ingredients

<acesulfame potassium, aspartame, eucalyptus oil, FDC blue 1, FDC red 40, flavors, isomalt, sodium carboxymethylcellulose, soy lecithin, water>

Description

&lt;(per drop) Menthol 5.8 mg&gt;

Purposes

<Cough Suppressant, Oral Anesthetic>

Questions

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

Active Ingredient

<(per drop) Menthol 5.8 mg>

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

Warnings

<Sore throat warning: if sore throat is severe, persist 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.>

Uses

<temporarily relieves:

  • cough due to a 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)
  • phenylketonurics: contains phenylalanine 2 mg per drop
  • excessive consumption may have a laxative effect
  • 5 calories per drop
  • contains soy



Inactive Ingredients (Inactive ingredients)

<acesulfame potassium, aspartame, eucalyptus oil, FDC blue 1, FDC red 40, flavors, isomalt, sodium carboxymethylcellulose, soy lecithin, water>

Purposes

<Cough Suppressant, Oral Anesthetic>

Questions

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

Active Ingredient

<(per drop) Menthol 5.8 mg>

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)