Xpect Honey Lemon Cough Drops Lozenge
FDA Label NDC 42961-233

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cintas Corporation for the product Xpect Honey Lemon Cough Drops (NDC 42961-233). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each drop)

Menthol 9 mg

Otc - Purpose

Purpose

Cough suppressant/oral anesthetic

Indications & Usage

Uses

temporarily relieves:

  • cough due to a cold
  • occasional minor irritation or sore throat

Warnings

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, swelling, nausea, or vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days unless directed by a doctor

Otc - Ask Doctor

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) 

Otc - Stop Use

Stop use and ask a doctor if

  • cough persists for more than 1 week, tends to recur, or is accompanies by fever, rash, or persistent headache. These could be signs of a serious condition.
  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Directions

  • do not take more than directed
  • adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed. 
  • children under 5 years: ask a doctor

Other Safety Information

Other information

  • 12 calories per drop
  • Contains: SOY

Inactive Ingredient

Inactive ingredients

beta carotene (color), corn syrup, eucalyptus oil, honey, natural & artificial flavors, soy lecithin, sucrose, water

Otc - Questions

Questions or comments?

1-877-973-2811 Monday - Friday 8:00 am - 5:00 pm

Principal Display Panel - 42961-233-02

HONEY LEMON COUGH DROP

Menthol

Cough suppressant/oral anesthetic

  • Soothes sore throat
  • Temporarily relieves cough
  • Contains a menthol cough suppressant and oral anesthetic

    • Xpect® First aid

    50 Individually Wrapped Drops

    50box (50box)

    50box (50box)

Principal Display Panel - 42961-233-03

HONEY LEMON COUGH DROP

Menthol

Cough suppressant/oral anesthetic

  • Soothes sore throat
  • Temporarily relieves cough
  • Contains a menthol cough suppressant and oral anesthetic

    • Xpect® First aid

    100 Individually Wrapped Drops

    100box (100box)

    100box (100box)

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