Herbal Flavor Menthol Cough Drops

Herbal Flavor Menthol Cough Drops
SPL v1
SPL
SPL Set ID 1eb848b6-3dec-5b5f-e063-6394a90aea14
Route
ORAL
Published
Effective Date 2024-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: P Shape: oval Color: brown Size: 25 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-02

Description

Active ingredient 4.8 mg Cough Suppressant 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.

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 ask a doctor
Description

Active ingredient 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 a doctor if

  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persisten headache. These could be signs of a serious condition
  • sore mouth symptons do not improve in 7 days or if irritation, pain or redness persists or worsens.
Section 50569-3

Ask a doctor before use if you have

  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough accompany by excessive phem (mucus)
Section 51727-6

glucose syrup, sugar, caramel color, natural flavor, herbal extract blend (elderflower extract, horehound extract, hyssop extract, lemon balm extract, linden flower extract, marshmallow root, peppermint extract, sage extractm thyme extract, wild thyme extract

Section 51945-4

Section 53413-1

Questions? or to report and adverse event call: 1-800-936-8255

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 4.8 mg

Cough Suppressant

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 ask 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.

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 for more than 7 days, tends to recur, or is accompanied by fever, rash or persisten headache. These could be signs of a serious condition
  • sore mouth symptons do not improve in 7 days or if irritation, pain or redness persists or worsens.
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 accompany by excessive phem (mucus)
Section 51727-6 (51727-6)

glucose syrup, sugar, caramel color, natural flavor, herbal extract blend (elderflower extract, horehound extract, hyssop extract, lemon balm extract, linden flower extract, marshmallow root, peppermint extract, sage extractm thyme extract, wild thyme extract

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? or to report and adverse event call: 1-800-936-8255

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 4.8 mg

Cough Suppressant

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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