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

Description

(per drop) Pectin 7 mg

Purpose

<Oral Demulcent>


Medication Information

Purpose

<Oral Demulcent>

Description

(per drop) Pectin 7 mg

Uses

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

  • minor discomfort
  • irritated areas>
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.>

Questions

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

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
Active Ingredient

(per drop) Pectin 7 mg

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

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

Uses

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

  • minor discomfort
  • irritated areas>
Purpose

<Oral Demulcent>

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.>

Questions

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

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
Active Ingredient

(per drop) Pectin 7 mg

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

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)