FDA.reportPublic FDA data

TENALIF

Manufacturer
OPMX LLC
Effective date
2026-09-24
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-09-30 01:02:16

Label at a glance#

ProductGUAIFENESIN, DEXTROMETHORPHAN HBR
Active ingredientGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure13 sections

Indications and uses

helps looseen 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 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

VERSIÓN EN ESPAÑOL EN EL INTERIOR DE LA CAJA

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.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 TESAPERLASTENALIF TESAPERLAS

TENALIF TESAPERLAS DRUGFACTS SPANISHTENALIF TESAPERLAS DRUGFACTS SPANISH

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130856828008434GTIN-13: 0856828008434
EAN-13: 0856828008434
GTIN-12: 856828008434
UPC-A: 856828008434
GTIN storage (14 digits): 00856828008434		Tenalif Tesaperlas.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-783-022024-05-17C16284748780-1d6a99b39-fd02-a426-e053-dadaa90af4c2TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
69729-783-022024-05-17C16284748780-1d6a99b39-fd02-a426-e053-dadaa90af4c2TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
69729-783-022024-01-30C16284748780-1d6a99b39-fd02-a426-e053-dadaa90af4c2TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
69729-783-022024-01-30C16284748780-1d6a99b39-fd02-a426-e053-dadaa90af4c2TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
69729-783-022022-09-20C16284748780-1d6a99b39-fd02-a426-e053-dadaa90af4c2TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
69729-783-022022-09-20C16284748780-1d6a99b39-fd02-a426-e053-dadaa90af4c2TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
69729-783-022022-01-28C16284748780-1d6a99b39-fd02-a426-e053-dadaa90af4c2TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
69729-783-022022-01-28C16284748780-1d6a99b39-fd02-a426-e053-dadaa90af4c2TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-78369729-783-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL SOLUTION8KW3E207O2IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
GLYCERINPDC6A3C0OXIACT
GELATIN2G86QN327LIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
SORBITAN6O92ICV9RUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-05-17full-release2026-06-01 00:12:43

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUAIFENESIN, DEXTROMETHORPHAN HBRGUAIFENESIN, DEXTROMETHORPHAN HBROPMX LLC9a246099-72b5-2efc-e053-2a95a90aafbc2024-05-17WarningsExact identifier
ndc (package): 69729-783-02
ndc (product): 69729-783
ndc11 (package): 69729078302
spl set id: 9a246099-72b5-2efc-e053-2a95a90aafbc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.