The Original Natural Herb Cough Drops Cough Suppressant Throat Drops

The Original Natural Herb Cough Drops Cough Suppressant Throat Drops
SPL v13
SPL
SPL Set ID 3fe3cddc-07ff-4428-b0c8-a3f91aa7d737
Route
ORAL
Published
Effective Date 2021-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4.8 mg)
Inactive Ingredients
Sucrose Caramel

Identifiers & Packaging

Pill Appearance
Shape: rectangle Color: brown Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 1942-01-01 Until 2016-01-01

Description

Purpose Cough suppressant, Oral anesthetic


Medication Information

Description

Purpose Cough suppressant, Oral anesthetic

Uses

temporarily relieves:

  • cough due to a cold or inhaled irritants
  • occasional minor irritation and pain due to sore throat or sore mouth
Section 51945-4

Warnings

Sore throat warnings:

  • 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.
  • do not use in children under 6 years of age unless directed by a doctor.
Directions
  • adults and children 6 years and older:  dissolve 2 drops (one at a time) slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor
Drug Facts

Purpose

Cough suppressant, Oral anesthetic

Other Information

Store in a dry place

Inactive Ingredients
color (caramel), extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), natural flavor, starch syrup, sugar
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.



Active Ingredient (in Each Drop)

Menthol, 4.8 mg

Ask Doctor Before Use If You Have
  • persistent 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 or inhaled irritants
  • occasional minor irritation and pain due to sore throat or sore mouth
Section 51945-4 (51945-4)

Warnings

Sore throat warnings:

  • 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.
  • do not use in children under 6 years of age unless directed by a doctor.
Directions
  • adults and children 6 years and older:  dissolve 2 drops (one at a time) slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor
Drug Facts

Purpose

Cough suppressant, Oral anesthetic

Other Information

Store in a dry place

Inactive Ingredients
color (caramel), extract of a Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), natural flavor, starch syrup, sugar
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.)



Active Ingredient (in Each Drop) (Active Ingredient (in each drop))

Menthol, 4.8 mg

Ask Doctor Before Use If You Have (Ask doctor before use if you have)
  • persistent 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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