SPL v2
SPL
SPL Set ID 71b567df-844a-4563-b85a-f4592233f37d
Route
ORAL
Published
Effective Date 2024-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg)
Inactive Ingredients
Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A

Identifiers & Packaging

Pill Appearance
Imprint: DEX Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-10

Description

(in each tablet) Dextromethrophan HBr 15 mg

Purpose

Cough suppressant


Medication Information

Purpose

Cough suppressant

Dosage and Administration

​Directions

  • only use this product according to these directions or as directed by a doctor
  • do not exceed 8 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 2 tablets every 6 to 8 hours, as needed

children under 12 years do not use

Description

(in each tablet) Dextromethrophan HBr 15 mg

Uses

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

Section 42229-5

Distributed by:

DXM Pharmaceutical, Inc. 2717 Commercial Center Blvd., Suite E200

Katy, TX 77 494

www.RoboCough.com.

Warning

Do not useif 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.

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

Product Label

Active Ingredient

(in each tablet) Dextromethrophan HBr 15 mg

Other Information 

• store at 20-25°C (68-77°F). Do not refrigerate.

• 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.


Structured Label Content

Uses

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

Dosage and Administration (34068-7)

​Directions

  • only use this product according to these directions or as directed by a doctor
  • do not exceed 8 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 2 tablets every 6 to 8 hours, as needed

children under 12 years do not use

Section 42229-5 (42229-5)

Distributed by:

DXM Pharmaceutical, Inc. 2717 Commercial Center Blvd., Suite E200

Katy, TX 77 494

www.RoboCough.com.

Purpose

Cough suppressant

Warning

Do not useif 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.

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

Product Label (Product label)

Active Ingredient (Active ingredient)

(in each tablet) Dextromethrophan HBr 15 mg

Other Information  (Other information )

• store at 20-25°C (68-77°F). Do not refrigerate.

• TAMPER EVIDENT: Do not use if safety seal under child-resistant cap is broken or missing.

Inactive Ingredients (Inactive ingredients)

magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments? (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.


Advanced Ingredient Data


Raw Label Data

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