Robotablets

Robotablets
SPL v9
SPL
SPL Set ID 0af624ce-191f-45e1-882b-e8acb90cc77b
Route
ORAL
Published
Effective Date 2022-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg)
Inactive Ingredients
Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A

Identifiers & Packaging

Pill Appearance
Imprint: R30 Shape: round Color: white Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-31

Description

Dextromethorphan Hbr 30 mg

Purpose

Cough suppressant 


Medication Information

Purpose

Cough suppressant 

Description

Dextromethorphan Hbr 30 mg

Uses

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

Section 50565-1

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)

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 ifa 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.

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.
Product Label

Active Ingredients

Dextromethorphan Hbr 30 mg

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.


Structured Label Content

Uses

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

Section 50565-1 (50565-1)

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)

Purpose

Cough suppressant 

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 ifa 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.

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.
Product Label (Product label)

Active Ingredients

Dextromethorphan Hbr 30 mg

Inactive Ingredients (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.


Advanced Ingredient Data


Raw Label Data

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