Cough Drops

Cough Drops
SPL v1
SPL
SPL Set ID eff19665-736d-fb9d-e053-2a95a90a9dcf
Route
ORAL
Published
Effective Date 2022-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5.8 mg)
Inactive Ingredients
Corn Syrup Sucrose Citric Acid Monohydrate Honey Turmeric

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: oval Color: yellow Size: 25 mm
Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-12-14
Description

Active ingredient 7.5 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 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 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
  • Children under 12 years and under do not use
Description

Active ingredient 7.5 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

  • 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

citric acid, honey, flavors, glucose syrup, sucrose, turmeric

Section 51945-4

Section 53413-1

Questions? or to report and adverse event call: 1-800-423-0139

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 7.5 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 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
  • Children under 12 years and under do not use
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)

citric acid, honey, flavors, glucose syrup, sucrose, turmeric

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? or to report and adverse event call: 1-800-423-0139

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 7.5 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:26.290374 · Updated: 2026-03-14T23:00:52.351984