Robitussin Medi-soothers Lozenge
FDA Label NDC 0031-9307

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Robitussin Medi-soothers (NDC 0031-9307). 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 active ingredients (in each lozenge), purposes, uses, sore throat warning, do not use, ask a doctor before use if you have, stop use and ask a doctor or dentist if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Lozenge)

Dextromethorphan HBr 5 mg

Menthol 5 mg

Purposes

Cough suppressant

Oral anesthetic

Uses

temporarily relieves

  • ▪cough due to minor throat and bronchial irritation as may occur with the common cold
  • ▪occasional minor irritation, pain, sore mouth, and sore throat

Sore Throat Warning

  • ▪if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly

Do Not Use

  • ▪if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • ▪persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • ▪cough that occurs with too much phlegm (mucus)

Stop Use And Ask A Doctor Or Dentist If

  • ▪cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • ▪sore mouth symptoms do not improve in 7 days
  • ▪irritation, pain, or redness persists or worsens

Directions

  • ▪adults and children 12 years of age and older: take 2 lozenges (one immediately after the other) every 4 hours as needed. Allow each lozenge to dissolve slowly in the mouth.
  • ▪do not take more than 12 lozenges in any 24-hour period, or as directed by a doctor
  • ▪children under 12 years of age: do not use

Other Information

  • ▪store at 20°-25°C (68°-77°F)

Inactive Ingredients

corn syrup, elderberry juice concentrate, glycerin, natural flavors, propylene glycol, purified water, soy lecithin, sucralose, sucrose

Questions Or Comments?

call weekdays from 8 am to 6 pm EST at 1-800-245-1040

Additional Information

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Keep carton for complete information.

Do not use if blister is broken or damaged.

Distributed by: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

©2023 Haleon or licensor.

For more recent product information, visit www.robitussin.com

Principal Display Panel

NEW! ADULT

Robitussin

Elderberry

MEDI-SOOTHERS

DEXTROMETHORPHAN HBr (Cough Suppressant) 5 mg

Menthol (Oral Anesthetic) 5 mg

Cough + Sore Throat

Taste the Real Elderberry

  • ✓Relieves Cough for up to 4 HOURS
  • ✓Relieves Sore Throat Pain

    • Elderberry Flavor

    Actual Size

    For Ages 12+

    16 MEDICATED LOZENGES

    202559 Front Carton

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