Pentrexcilina Expectorant & Cough Suppressant

Pentrexcilina Expectorant & Cough Suppressant
SPL v7
SPL
SPL Set ID 9a16e7f3-78aa-0b01-e053-2a95a90ab19c
Route
ORAL
Published
Effective Date 2019-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Water D&c Yellow No. 10 Propylene Glycol Sorbitol Polyethylene Glycol 400 Glycerin Gelatin Povidone K30 Sodium Hydroxide Sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: 781 Shape: oval Color: yellow Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-18

Description

Dextromethorphan HBr 20mg Guaifenesin 400mg


Medication Information

Warnings and Precautions

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:

  • Cough that occurs with too much phlegm (mucus)
  • Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if:

Cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition

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

Keep out of reach of children.

Indications and Usage

Helps loosen phlegm (mucus)

Helps thin bronchial secretions to make coughs more productive

Dosage and Administration

Do not take more than directed – See overdose warning

Do not use for more than 7 days

Do not take more than 6 doses in 24 hours

Adults and children 12 years of age and over: take 1 softgel every 4 hours with a full glass of water while symptoms persist

Children under 12 years of age: do not use

Description

Dextromethorphan HBr 20mg Guaifenesin 400mg

Section 34088-5

OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50565-1

Keep out of reach of children

Section 51727-6

FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

Section 51945-4

Section 55105-1

Cough suppressant

Expectorant

Section 55106-9

Dextromethorphan HBr 20mg

Guaifenesin 400mg

Section 60561-8

store at room temperature between 20-25°C (68-77ºF)

avoid excessive heat and humidity


Structured Label Content

Indications and Usage (34067-9)

Helps loosen phlegm (mucus)

Helps thin bronchial secretions to make coughs more productive

Dosage and Administration (34068-7)

Do not take more than directed – See overdose warning

Do not use for more than 7 days

Do not take more than 6 doses in 24 hours

Adults and children 12 years of age and over: take 1 softgel every 4 hours with a full glass of water while symptoms persist

Children under 12 years of age: do not use

Warnings and Precautions (34071-1)

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:

  • Cough that occurs with too much phlegm (mucus)
  • Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if:

Cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition

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

Keep out of reach of children.

Section 34088-5 (34088-5)

OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Cough suppressant

Expectorant

Section 55106-9 (55106-9)

Dextromethorphan HBr 20mg

Guaifenesin 400mg

Section 60561-8 (60561-8)

store at room temperature between 20-25°C (68-77ºF)

avoid excessive heat and humidity


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)