Original Herb Cough Drops

Original Herb Cough Drops
SPL v3
SPL
SPL Set ID c142663f-086e-4ab7-a758-9107d7077537
Route
ORAL
Published
Effective Date 2022-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5.5 mg)
Inactive Ingredients
Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: R Shape: rectangle Color: red Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-01

Description

Purpose Cough supressant, Oral anesthetic


Medication Information

Description

Purpose Cough supressant, 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 1 drop slowly in the mouth.  Do not bite or chew.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor
Drug Facts

Purpose

Cough supressant, Oral anesthetic

Other Information

protect from heat and moisture

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

Keep Out of Reach of Children.



Active Ingredient (in Each Drop)

Menthol, 5.5 mg

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)

​Stop use and ask 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.

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 1 drop slowly in the mouth.  Do not bite or chew.  Repeat every 2 hours as needed or as directed by a doctor
  • children under 6 years: ask a doctor
Drug Facts

Purpose

Cough supressant, Oral anesthetic

Other Information

protect from heat and moisture

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

Keep Out of Reach of Children. (Keep out of reach of children.)



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

Menthol, 5.5 mg

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)

​Stop use and ask 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.

Advanced Ingredient Data


Raw Label Data

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