Tesalon Tesaperlas Severe Cold Max Relief

Tesalon Tesaperlas Severe Cold Max Relief
SPL v2
SPL
SPL Set ID 23223821-4fa0-5d99-e063-6394a90af0e5
Route
ORAL
Published
Effective Date 2024-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Sorbitol Sorbitan Propylene Glycol Gelatin Glycerin Povidone Polyethylene Glycol, Unspecified Water D&c Yellow No. 10 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 781 Shape: oval Color: yellow Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-27

Description

Active Ingredients (in each softgel) Purpose Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant


Medication Information

Dosage and Administration
Adults and children 12 years of age & 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

Active Ingredients (in each softgel) Purpose Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant

Uses
  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive
Section 51945-4

NDC 69729-788-20

Tesalon®

Tesaperlas

Adults

Expectorant & Cough Suppressant

Expectorante & Supresor de la Tos

Controls cough

Controla la tos

Thins & loosens mucus

Adelgaza y expulsa las flemas

SOFTGELS

Dextromethorphan HBr 20 mg / Guaifenesin 400 mg

20 Softgels Box

Read & keep package for complete product information

TAMPER EVIDENT; DO NOT USE IS PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Warnings

Warnings

Directions:
  • Do not take more than directed- See Overdose warning
  • Do not use for more than 7 days.
  • Do not take more than 6 softgels in 24 hours

Do Not Use:
  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkison´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.
Overdose Warning:

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

Other Information:
  • Store at room temperature between 20-25°C (68-77°F)
  • Avoid excessive heat and humidity
Inactive Ingredients:

FD&C yellow No. 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, sorbitan solution, titanium dioxide.

Questions Or Comments?

Call: (619) 600-5632 (Mon-Fri 9am-5pm EST)

Stop Use and Ask A Doctor If:
  • cough lasts 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.
Active Ingredients (in Each Softgel)
Active Ingredients (in each softgel) Purpose
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant

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

Structured Label Content

Uses
  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive
Dosage and Administration (34068-7)
Adults and children 12 years of age & 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

Section 51945-4 (51945-4)

NDC 69729-788-20

Tesalon®

Tesaperlas

Adults

Expectorant & Cough Suppressant

Expectorante & Supresor de la Tos

Controls cough

Controla la tos

Thins & loosens mucus

Adelgaza y expulsa las flemas

SOFTGELS

Dextromethorphan HBr 20 mg / Guaifenesin 400 mg

20 Softgels Box

Read & keep package for complete product information

TAMPER EVIDENT; DO NOT USE IS PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Warnings

Warnings

Directions:
  • Do not take more than directed- See Overdose warning
  • Do not use for more than 7 days.
  • Do not take more than 6 softgels in 24 hours

Do Not Use: (Do not use:)
  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkison´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.
Overdose Warning: (Overdose warning:)

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

Other Information: (Other information:)
  • Store at room temperature between 20-25°C (68-77°F)
  • Avoid excessive heat and humidity
Inactive Ingredients:

FD&C yellow No. 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, sorbitan solution, titanium dioxide.

Questions Or Comments? (Questions or comments?)

Call: (619) 600-5632 (Mon-Fri 9am-5pm EST)

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • cough lasts 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: (If pregnant or breast-feeding:)
  • ask a health professional before use.
Active Ingredients (in Each Softgel) (Active Ingredients (in each softgel))
Active Ingredients (in each softgel) Purpose
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant

Ask A Doctor Before Use If You Have: (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

Advanced Ingredient Data


Raw Label Data

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