Natural Herbal Cough Drops

Natural Herbal Cough Drops
SPL v3
SPL
SPL Set ID c2340f56-9a8e-4eea-e053-2995a90a78fc
Route
ORAL
Published
Effective Date 2020-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: oval Color: brown Size: 25 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-12

Description

Active Ingredient in each drop Purposes Menthol 4.8 mg Cough Suppressant Oral Anesthetic


Medication Information

Warnings and Precautions

Warnings

Sore throat warning: is sore throat is severe, persist for more than 2 days, is accompanied or followed by fever headache, rash, swelling, nausea and vomiting maybe serious 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

Purposes

Temporarily relieves :

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

Dosage and Administration

Directions

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

Active Ingredient in each drop Purposes Menthol 4.8 mg 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 doctor if

  • cough persist for more than 7 days or tends to recur or is accompanied by fever, rash or persistent headache. These could be signs of a serious conditions
  • sore throat is severe or irritation, pain or redness lasts 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 ephysema.
  • Cough accompanied by excessive pleghm (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 an adverse event call:

1 800 632 6800

Section 53414-9

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

Section 55105-1

Purposes

Temporarily relieves :

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

Active Ingredient in each drop Purposes

Menthol 4.8 mg

Cough Suppressant

Oral Anesthetic

Section 60561-8

Other information

  • Store in a cool and dry place
  • 11 calories per drop

Structured Label Content

Indications and Usage (34067-9)

Purposes

Temporarily relieves :

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

Dosage and Administration (34068-7)

Directions

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

Warnings

Sore throat warning: is sore throat is severe, persist for more than 2 days, is accompanied or followed by fever headache, rash, swelling, nausea and vomiting maybe serious 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 doctor if

  • cough persist for more than 7 days or tends to recur or is accompanied by fever, rash or persistent headache. These could be signs of a serious conditions
  • sore throat is severe or irritation, pain or redness lasts 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 ephysema.
  • Cough accompanied by excessive pleghm (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 an adverse event call:

1 800 632 6800

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Temporarily relieves :

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

Active Ingredient in each drop Purposes

Menthol 4.8 mg

Cough Suppressant

Oral Anesthetic

Section 60561-8 (60561-8)

Other information

  • Store in a cool and dry place
  • 11 calories per drop

Advanced Ingredient Data


Raw Label Data

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