halls sugar free cool berry

halls sugar free cool berry
SPL v7
SPL
SPL Set ID dd1b4b17-4f73-4052-9589-d5fd6bb059bb
Route
oral
Published
Effective Date 2019-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pectin (7 mg)
Inactive Ingredients
acesulfame potassium aspartame anhydrous citric acid fd&c blue no. 2 fd&c red no. 40 isomalt malic acid maltitol potassium citrate lecithin, soybean titanium dioxide water

Identifiers & Packaging

Pill Appearance
Imprint: H Shape: oval Color: red Size: 21 mm Score: 1
Marketing Status
otc monograph drug active Since 2019-05-27

Purpose

<Oral Demulcent>

Description

(per drop) Pectin 7 mg


Medication Information

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.>

Uses

<temporarily relieves the following symptoms associated with sore mouth and sore throat:

  • minor discomfort
  • irritated areas>
Purpose

<Oral Demulcent>

Directions
  • adults and children 5 years and over: dissolve 1 or 2 drops (one at a time) slowly in the mouth.  Repeat 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
  • 10 calories per drop
  • Contains: SOY.
Inactive Ingredients

acesulfame potassium, aspartame, citric acid, FDC blue 2, FDC red 40, flavors, isomalt, malic acid, maltitol syrup, potassium citrate, soy lecithin, titanium dioxide, water

Description

(per drop) Pectin 7 mg

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) Pectin 7 mg

Otc Principal Display Panel

Stop Use and Ask A Doctor If
  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens

Keep Out of Reach of Children



Structured Label Content

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.>

Uses

<temporarily relieves the following symptoms associated with sore mouth and sore throat:

  • minor discomfort
  • irritated areas>
Purpose

<Oral Demulcent>

Directions
  • adults and children 5 years and over: dissolve 1 or 2 drops (one at a time) slowly in the mouth.  Repeat 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
  • 10 calories per drop
  • Contains: SOY.
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, aspartame, citric acid, FDC blue 2, FDC red 40, flavors, isomalt, malic acid, maltitol syrup, potassium citrate, soy lecithin, titanium dioxide, water

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) Pectin 7 mg

Otc Principal Display Panel (OTC Principal Display Panel)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • 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)



Advanced Ingredient Data


Raw Label Data

All Sections (JSON)