Natural Herb Cough Drops

Natural Herb Cough Drops
SPL v2
SPL
SPL Set ID fcd16063-abca-49a0-e053-6294a90acb26
Route
ORAL
Published
Effective Date 2023-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4.8 mg)
Inactive Ingredients
Peppermint Horehound Melissa Officinalis Flower Thyme Tilia Cordata Flower Sage Malva Sylvestris Leaf Caramel Corn Syrup Sucrose Sambucus Nigra Flower Hyssopus Officinalis Flowering Top Wild Thyme

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: oval Color: brown Size: 25 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-29

Description

Active Ingredient: Menthol 4.8 mg.............cough suppresant/ oral anesthetic


Medication Information

Warnings and Precautions

Warnings

Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

Indications and Usage

Uses temporarily relieves:

cough as may occur with a cold



ocassional minor irritation and sore throat

Dosage and Administration

Directions

  • Adults and children 6 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
  • Children under 6 years as a Doctor
Description

Active Ingredient: Menthol 4.8 mg.............cough suppresant/ 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

  • sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.
Section 50569-3

Ask a doctor before use if you have

  • a severe throat accompanied by difficulty in breathing or that last more than 2 days
  • a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting
Section 51727-6

caramel color, blend of herb extracts (elderflower, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme. wild thyme) glucose syrup, natural flavors, sucrose

Section 51945-4

Section 53413-1

Questions? or to report and adverse event call: 1-833-552-1767

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
  • ocassional minor irritation and sore throat
Section 55106-9

Active Ingredient:

  • Menthol 4.8 mg.............cough suppresant/ oral anesthetic
Section 60561-8
  • Store in a cool and dry place
  • 10 calories per drop

Structured Label Content

Indications and Usage (34067-9)

Uses temporarily relieves:

cough as may occur with a cold



ocassional minor irritation and sore throat

Dosage and Administration (34068-7)

Directions

  • Adults and children 6 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
  • Children under 6 years as a Doctor
Warnings and Precautions (34071-1)

Warnings

Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

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

  • sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • a severe throat accompanied by difficulty in breathing or that last more than 2 days
  • a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting
Section 51727-6 (51727-6)

caramel color, blend of herb extracts (elderflower, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme. wild thyme) glucose syrup, natural flavors, sucrose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? or to report and adverse event call: 1-833-552-1767

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
  • ocassional minor irritation and sore throat
Section 55106-9 (55106-9)

Active Ingredient:

  • Menthol 4.8 mg.............cough suppresant/ oral anesthetic
Section 60561-8 (60561-8)
  • Store in a cool and dry place
  • 10 calories per drop

Advanced Ingredient Data


Raw Label Data

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