Natural Herbal Cough Drops

Natural Herbal Cough Drops
SPL v2
SPL
SPL Set ID a23ddfa9-19e0-99ee-e053-2a95a90a6856
Route
ORAL
Published
Effective Date 2020-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4.8 mg)
Inactive Ingredients
Caramel Horehound Sambucus Nigra Flower Hyssopus Officinalis Flowering Top Sucrose Corn Syrup Thyme Lemon Balm Oil Peppermint Levoisomethadone Wild Thyme Sage Malva Sylvestris Leaf

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: oval Color: brown Size: 25 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-01

Description

Active Ingredient in each drop Purposes Menthol 20mg Cough Suppressant Oral anesthetic


Medication Information

Warnings and Precautions

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 and vomiting consult a doctor promptly. If sore mouth symptons do not improve in 7 days see your dentist or doctor promptly. These symptons may be serious.

Indications and Usage

Uses Temporarily relieves:

  • cough as may occur with a cold
  • ocasional minor irritation and sore throat

Dosage and Administration

Directions

  • Adults and children 12 years and over: allow 2 drops slowly in mouth one a time. Maybe repeated every 2 hours as necessary or as directed by a doctor.
  • Children under 6 years ask a doctor
Description

Active Ingredient in each drop Purposes Menthol 20mg Cough Suppressant Oral anesthetic

Section 34088-5

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

Section 50565-1

Keep this and all drugs out of the reach of children.

Section 50566-9

Stop use and consult a doctor if

  • cough persists more than 7 days, tends to recur or is accompanied by fever, headache, rash or persistent headache. These could be signs of serious conditions.
  • sore throat is severe or irritation, pain or redness last or worsens
  • sore mouth does not improve in 7 days

Section 50569-3

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)
Section 51727-6

GLUCOSE SYRUP, SUCROSE, CARAMEL COLOR, ELDERFLOWER, HONEHOUND, HYSSOP, LEMON BALM, LIDEN FIWER, MALOW, PEPPERMINT, SAGE, THYME, WILD THYME, Natural flavours

Section 51945-4

Section 53413-1

Questions? or to report and adverse event call: 1-617-848-4560

Monday to Friday 9AM to 4 PM east

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses Temporarily relieves:

  • cough as may occur with a cold
  • ocasional minor irritation and sore throat
Section 55106-9

Active Ingredient in each drop Purposes

Menthol 20mg Cough Suppressant

Oral anesthetic

Section 60561-8
  • Store in a cool and dry place

Structured Label Content

Indications and Usage (34067-9)

Uses Temporarily relieves:

  • cough as may occur with a cold
  • ocasional minor irritation and sore throat

Dosage and Administration (34068-7)

Directions

  • Adults and children 12 years and over: allow 2 drops slowly in mouth one a time. Maybe repeated every 2 hours as necessary or as directed by a doctor.
  • Children under 6 years ask a doctor
Warnings and Precautions (34071-1)

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 and vomiting consult a doctor promptly. If sore mouth symptons do not improve in 7 days see your dentist or doctor promptly. These symptons may be serious.

Section 34088-5 (34088-5)

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

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children.

Section 50566-9 (50566-9)

Stop use and consult a doctor if

  • cough persists more than 7 days, tends to recur or is accompanied by fever, headache, rash or persistent headache. These could be signs of serious conditions.
  • sore throat is severe or irritation, pain or redness last or worsens
  • sore mouth does not improve in 7 days

Section 50569-3 (50569-3)

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)
Section 51727-6 (51727-6)

GLUCOSE SYRUP, SUCROSE, CARAMEL COLOR, ELDERFLOWER, HONEHOUND, HYSSOP, LEMON BALM, LIDEN FIWER, MALOW, PEPPERMINT, SAGE, THYME, WILD THYME, Natural flavours

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? or to report and adverse event call: 1-617-848-4560

Monday to Friday 9AM to 4 PM east

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses Temporarily relieves:

  • cough as may occur with a cold
  • ocasional minor irritation and sore throat
Section 55106-9 (55106-9)

Active Ingredient in each drop Purposes

Menthol 20mg Cough Suppressant

Oral anesthetic

Section 60561-8 (60561-8)
  • Store in a cool and dry place

Advanced Ingredient Data


Raw Label Data

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