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

TESALON Tesaperlas Severe Cold Max Relief by

Drug Labeling and Warnings

TESALON Tesaperlas Severe Cold Max Relief by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, Medgel Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Active Ingredients (in each softgel)

• 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

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 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.

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

DOSAGE & 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

Other information:

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

Inactive Ingredients:

D&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)

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 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-788
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE (UNII: FZ989GH94E)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	781
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-788-20	1 in 1 CARTON	09/27/2024
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/27/2024

Labeler - OPMX LLC (029918743)

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