halls minis sugar free cherry 24ct

halls minis sugar free cherry 24ct
SPL v13
SPL
SPL Set ID ea8dfe96-f6a4-4172-bf9e-ae3cf606ff50
Route
oral
Published
Effective Date 2021-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (2.9 mg)
Inactive Ingredients
acesulfame potassium aspartame eucalyptus oil fd&c blue no. 2 fd&c red no. 40 isomalt lecithin, soybean water

Identifiers & Packaging

Pill Appearance
Imprint: H Shape: round Color: red Size: 9 mm Score: 1
Marketing Status
otc monograph drug completed Since 2020-10-21 Until 2022-10-03

Purpose

<Cough Suppressant, Oral Anesthetic>

Description

<(per drop) Menthol 2.9 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 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor
Other Information
  • phenylketonurics: contains phenylalanine 1 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 2, FDC red 40, flavors, isomalt, soy lecithin, water>

Description

&lt;(per drop) Menthol 2.9 mg&gt;

Section 51945-4

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 2.9 mg>

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. 

In case of overdose, get medical help or contact a Poison Control Center right away

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 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor
Other Information (Other information)
  • phenylketonurics: contains phenylalanine 1 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 2, FDC red 40, flavors, isomalt, soy lecithin, water>

Section 51945-4 (51945-4)

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 (Active ingredient)

<(per drop) Menthol 2.9 mg>

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. )

In case of overdose, get medical help or contact a Poison Control Center right away

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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