Halls Breezers Creamy Strawberry

Halls Breezers Creamy Strawberry
SPL v9
SPL
SPL Set ID 777fd6db-f129-4489-8312-4b1aca94878e
Route
ORAL
Published
Effective Date 2019-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pectin (7 mg)
Inactive Ingredients
.beta.-carotene Anhydrous Citric Acid Fd&c Blue No. 2 Fd&c Red No. 40 Lactic Acid Malic Acid Potassium Citrate Sodium Chloride Lecithin, Soybean Sucrose Titanium Dioxide Water

Identifiers & Packaging

Pill Appearance
Imprint: H Shape: oval Color: white Size: 22 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-08-03 Until 2022-09-16

Description

<(per drop) Pectin 7 mg>

Purpose

<Oral demulcent>


Medication Information

Purpose

<Oral demulcent>

Description

&lt;(per drop) Pectin 7 mg&gt;

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, 9AM-5PM 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

<•15 calories

• Contains: SOY.>

Inactive Ingredients

<beta carotene, citric acid, FDC blue 2, FDC red 40, flavors, glucose syrup, lactic acid, malic acid, potassium citrate, sodium chloride, soy lecithin, sucrose, 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

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


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, 9AM-5PM 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)

<•15 calories

• Contains: SOY.>

Inactive Ingredients (Inactive ingredients)

<beta carotene, citric acid, FDC blue 2, FDC red 40, flavors, glucose syrup, lactic acid, malic acid, potassium citrate, sodium chloride, soy lecithin, sucrose, 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)

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


Advanced Ingredient Data


Raw Label Data

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