DailyMed - TESALON TESAPERLAS SEVERE COLD MAX RELIEF- dextromethorphan hbr, guaifenesin capsule, liquid filled

NDC Code(s): 69729-788-20
Packager: OPMX LLC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated September 27, 2024

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Active ingredients
Active Ingredients (in each softgel) Active Ingredients (in each softgel)Purpose - Dextromethorphan HBr 20 mgCough suppressant - Guaifenesin 400 mgExpectorant

Active Ingredients (in each softgel)

Active Ingredients (in each softgel) Purpose

Dextromethorphan HBr 20 mg Cough suppressant

Guaifenesin 400 mg Expectorant

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Uses
helps loosen phlegm (mucus) helps thin bronchial secretions to make coughs more productive
- helps loosen phlegm (mucus)
- helps thin bronchial secretions to make coughs more productive
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Warnings
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 ...
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.
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 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

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.

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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 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
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DOSAGE & ADMINISTRATION
Adults and children 12 years of age & overTake 1 softgel every 4 hours with a full glass of water while symptoms persist - Children under 12 years of ageDo not use

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

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Other information:
Store at room temperature between 20-25°C (68-77°F) Avoid excessive heat and humidity
- Store at room temperature between 20-25°C (68-77°F)
- Avoid excessive heat and humidity
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Inactive Ingredients:
D&C yellow No. 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, sorbitan solution, titanium dioxide.

D&C yellow No. 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, sorbitan solution, titanium dioxide.
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Questions or comments?
Call: (619) 600-5632 (Mon-Fri 9am-5pm EST)

Call: (619) 600-5632 (Mon-Fri 9am-5pm EST)
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PRINCIPAL DISPLAY PANEL
Tesalon® Tesaperlas - Adults - Expectorant & Cough Suppressant - Expectorante & Supresor de la Tos - Controls cough - Controla la tos - Thins & loosens mucus - Adelgaza y expulsa las ...

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

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INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
Medgel Private Limited		677385498	manufacture(69729-788)

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	RxCUI	RxNorm NAME	RxTTY
1	1661740	dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral Capsule	PSN
2	1661740	dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Capsule	SCD

Label: TESALON TESAPERLAS SEVERE COLD MAX RELIEF- dextromethorphan hbr, guaifenesin capsule, liquid filled

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Active Ingredients (in each softgel)

Do not use:

Ask a doctor before use if you have:

Stop use and ask a doctor if:

If pregnant or breast-feeding:

Keep out of reach of children

Overdose warning:

Find additional resources

Safety

Related Resources

More Info on this Drug

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

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

Label: TESALON TESAPERLAS SEVERE COLD MAX RELIEF- dextromethorphan hbr, guaifenesin capsule, liquid filled

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Active Ingredients (in each softgel)

Do not use:

Ask a doctor before use if you have:

Stop use and ask a doctor if:

If pregnant or breast-feeding:

Keep out of reach of children

Overdose warning:

Find additional resources

Safety

Related Resources

More Info on this Drug

TESALON TESAPERLAS SEVERE COLD MAX RELIEF- dextromethorphan hbr, guaifenesin capsule, liquid filled

Number of versions: 1

TESALON TESAPERLAS SEVERE COLD MAX RELIEF- dextromethorphan hbr, guaifenesin capsule, liquid filled

TESALON TESAPERLAS SEVERE COLD MAX RELIEF- dextromethorphan hbr, guaifenesin capsule, liquid filled

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TESALON TESAPERLAS SEVERE COLD MAX RELIEF- dextromethorphan hbr, guaifenesin capsule, liquid filled

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.