GUAIFENESIN, DEXTROMETHORPHAN HBR- guaifenesin, dextromethorphan hbr capsule, liquid filled 
OPMX LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TENALIF

(DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)

Drug facts

Active ingredients (in each softgel) Purpose
Dextromethorphan HBr 20 mgCough Suppressant
Guaifenesin 400 mgExpectorant

Uses

helps looseen phlegm (mucus)
helps thin bronchial secretions to make coughs more productive

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 smooking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if

cough lasts for more than 7 days, recurs, or is accompained 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. Prompt 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

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 humiditydity

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)

VERSIÓN EN ESPAÑOL EN EL INTERIOR DE LA CAJA

Tenalif - Adults
Tesaperlas
Expectorant & Cough Suppressant
Dextromethorphan HBr 20 mg Guaifenesin 400 mg

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

Tenalif
Adults
Tesaperlas
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Expectorant & Cough Suppressant

Made for:
RRX

Exclusively distributed by:
OPMX
Chula Vista, CA 91910
Phones: 619-600-5632

TAMPER EVIDENT:
Do not use if package is opened or if blister unit is torn, broken or shows any sign of tampering

PRINCIPAL DISPLAY PANEL

NDC 69729-783-02
Tenalif® - Adults
Tesaperlas

Expectorante & Supresor de la Tos
Expectorant & Cough Suppressant

Controls cough
Controla la tos

Thins & loosens mucus
Adelgaza y expulsa las flemas

SOFTGELS
Dextromethorphan HBr 20 mg / Guaifenesin 400 mg
20 Softgels Box

TENALIF TESAPERLAS

TENALIF TESAPERLAS DRUGFACTS SPANISH

GUAIFENESIN, DEXTROMETHORPHAN HBR 
guaifenesin, dextromethorphan hbr capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-783
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN (UNII: 2G86QN327L)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
SORBITAN (UNII: 6O92ICV9RU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Coloryellow (LIGHT YELLOW) Scoreno score
ShapeOVAL (Oblong) Size20mm
FlavorImprint Code 781
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-783-022 in 1 CARTON02/18/2019
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/18/2019
Labeler - OPMX LLC (029918743)
Establishment
NameAddressID/FEIBusiness Operations
MEDGEL PRIVATE LIMITED677385498manufacture(69729-783)

Revised: 10/2022
Document Id: ea797ee5-0400-1961-e053-2995a90a7f3e
Set id: 9a246099-72b5-2efc-e053-2a95a90aafbc
Version: 4
Effective Time: 20221007
 
OPMX LLC