drug facts

drug facts
SPL v2
SPL
SPL Set ID 6bec225e-a203-4866-b0db-b76f73a6ae25
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
acacia ascorbyl palmitate beta carotene caramel corn syrup .alpha.-tocopherol, dl- glycerin maltodextrin medium-chain triglycerides honey propylene glycol water lecithin, soybean sucralose sucrose sunflower oil

Identifiers & Packaging

Pill Appearance
Imprint: R Shape: oval Color: yellow Size: 25 mm Score: 1
Marketing Status
otc monograph drug active Since 2023-06-01

Purpose

Cough suppressant Oral anesthetic

Description

Dextromethorphan HBr 5 mg Menthol 5 mg


Medication Information

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
Purpose

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
Inactive Ingredients

acacia, ascorbyl palmitate, beta carotene, caramel color, corn syrup, dl-alpha tocopherol, glycerin, maltodextrin, medium-chain triglycerides, natural flavors, natural grade A honey, propylene glycol, purified water, soy lecithin, sucralose, sucrose, sunflower oil

Description

Dextromethorphan HBr 5 mg Menthol 5 mg

Principal Display Panel

NEW! ADULT

Robitussin

Honey

MEDI-SOOTHERS

DEXTROMETHORPHAN HBr (Cough Suppressant) 5 mg

Menthol (Oral Anesthetic) 5 mg

Cough + Sore Throat

Taste the Real Honey

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

Honey Lemon Flavor

Actual Size

For Ages 12+

16 MEDICATED LOZENGES

202556 Front Carton



Purposes

Cough suppressant

Oral anesthetic

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.
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
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

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
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
Inactive Ingredients (Inactive ingredients)

acacia, ascorbyl palmitate, beta carotene, caramel color, corn syrup, dl-alpha tocopherol, glycerin, maltodextrin, medium-chain triglycerides, natural flavors, natural grade A honey, propylene glycol, purified water, soy lecithin, sucralose, sucrose, sunflower oil

Principal Display Panel

NEW! ADULT

Robitussin

Honey

MEDI-SOOTHERS

DEXTROMETHORPHAN HBr (Cough Suppressant) 5 mg

Menthol (Oral Anesthetic) 5 mg

Cough + Sore Throat

Taste the Real Honey

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

Honey Lemon Flavor

Actual Size

For Ages 12+

16 MEDICATED LOZENGES

202556 Front Carton



Purposes

Cough suppressant

Oral anesthetic

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.
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
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

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

All Sections (JSON)