Halls Minis Sugar Free Watermelon

Halls Minis Sugar Free Watermelon
SPL v4
SPL
SPL Set ID c4c090ca-f083-74e0-e053-2a95a90a9d60
Route
ORAL
Published
Effective Date 2021-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.5 mg)
Inactive Ingredients
Acesulfame Potassium Aspartame Lecithin, Soybean Anhydrous Citric Acid Water Eucalyptus Oil Fd&c Red No. 40 Isomalt

Identifiers & Packaging

Pill Appearance
Imprint: H Shape: round Color: pink Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-13

Description

(per drop) Menthol 2.5 mg

Purpose

Cough Suppressant, Oral Anesthetic


Medication Information

Purpose

Cough Suppressant, Oral Anesthetic

Description

(per drop) Menthol 2.5 mg

Uses

temporarily relieves:

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

Cough Suppressant, Oral Anesthetic

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

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 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor
Active Ingredient

(per drop) Menthol 2.5 mg

Other Information
  • phenylketonurics: contains phenylalanine 0.5 mg per drop
  • excessive consumption may have a laxative effect
  • <5 calories per drop
  • Contains: SOY.
Inactive Ingredients

acesulfame potassium, aspartame, citric acid, eucalyptus oil, FD&C red 40, flavors (includes cinnamon), isomalt, soy lecithin, water

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.

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

Uses

temporarily relieves:

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

Cough Suppressant, Oral Anesthetic

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

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 2 drops (one at a time) slowly in the mouth. Repeat every 2 hours as needed.
  • children under 5 years: ask a doctor
Active Ingredient

(per drop) Menthol 2.5 mg

Other Information (Other information)
  • phenylketonurics: contains phenylalanine 0.5 mg per drop
  • excessive consumption may have a laxative effect
  • <5 calories per drop
  • Contains: SOY.
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, aspartame, citric acid, eucalyptus oil, FD&C red 40, flavors (includes cinnamon), isomalt, soy lecithin, water

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.)

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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