OTC Medication Information: RoboHBr Cough SUPPRESSANT

ROBOHBR COUGH SUPPRESSANT- dextromethorphan hydrobromide tablet
DXM Pharmaceutical, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients

Dextromethorphan Hbr 30 mg

Purpose

Cough suppressant

Uses

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold.

Warnings

Do not use if you are now taking a 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

  • a cough that is accompanied by excessive phlegm (mucus), or
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema.

Stop use and ask a doctor if a cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding , ask a health professional before use.

Keep out of reach of children. ln case of overdose. get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • only use this product according to these directions or as directed by a doctor
  • do not exceed 4 tablets in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
Age Dose
adults and children 12 years and over take 1 tablet every 6 to 8 hours, as needed
children under 12 years do not use
  • Other Information
  • store at 20-25°C (68-77°F).
  • TAMPER EVIDENT: Do not use if safety seal under child-resistant cap is broken or missing.

Inactive ingredients

magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

Questions or comments?
Call weekdays between 10 a.m. to 4 p.m. CST, at 833-289-7626 or visit our website www.RoboCough.com to report serious adverse events associated with the use of this product. Please call a doctor for medical advice.

Distributed by:
DXM Pharmaceutical, Inc. 2717 Commercial Center Blvd., Suite E200
Katy, TX 77 494
www.RoboCough.com Patent Pending.

Product label

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ROBOHBR COUGH SUPPRESSANT
dextromethorphan hbr tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71598-100
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A
Product Characteristics
Color white Score no score
Shape ROUND Size 5mm
Flavor Imprint Code R30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71598-100-30 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/31/2022
Labeler — DXM Pharmaceutical, Inc (080748277)
Registrant — DXM Pharmaceutical, Inc (080748277)

Revised: 06/2022 DXM Pharmaceutical, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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