Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5
Route
ORAL
Published
Effective Date 2023-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Menthol, Unspecified Form
Inactive Ingredients
Corn Syrup European Elderberry Juice Glycerin Propylene Glycol Water Lecithin, Soybean Sucralose Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: R Shape: oval Color: purple Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-01

Description

Dextromethorphan HBr 5 mg Menthol 5 mg

Purpose

Cough suppressant Oral anesthetic


Medication Information

Purpose

Cough suppressant Oral anesthetic

Description

Dextromethorphan HBr 5 mg Menthol 5 mg

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
Purposes

Cough suppressant

Oral anesthetic

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
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.
Other Information
  • store at 20°-25°C (68°-77°F)
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
Inactive Ingredients

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

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

Questions Or Comments?

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

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

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)
Active Ingredients (in Each Lozenge)

Dextromethorphan HBr 5 mg

Menthol 5 mg

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

Structured Label Content

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
Purposes

Cough suppressant

Oral anesthetic

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
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.
Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
Sore Throat Warning (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
Inactive Ingredients (Inactive ingredients)

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

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

Questions Or Comments? (Questions or comments?)

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

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

Ask A Doctor Before Use If You Have (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)
Active Ingredients (in Each Lozenge) (Active ingredients (in each lozenge))

Dextromethorphan HBr 5 mg

Menthol 5 mg

Stop Use and Ask A Doctor Or Dentist If (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

Advanced Ingredient Data


Raw Label Data

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