FDA Label for Robitussin Medi-soothers
View Indications, Usage & Precautions
Robitussin Medi-soothers Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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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