FDA.reportPublic FDA data

tabcin EXTRA FUERTE

Manufacturer
OPMX LLC
Effective date
2026-10-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-10-13 04:05:17

Label at a glance#

Producttabcin Extra Strength
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Indications and uses

helps loosen 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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each softgel)

  • Dextromethorphan HBr 20 mg
  • Guaifenesin 400 mg

Active Ingredients (in each softgel)

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Warnings

Do not use:

SPL UNCLASSIFIED SECTION

  • 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:

OTC - ASK DOCTOR SECTION

  • 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:

OTC - STOP USE SECTION

  • 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:

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Overdose warning:

SPL UNCLASSIFIED SECTION

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:

INDICATIONS & USAGE 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

DOSAGE & ADMINISTRATION SECTION

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

Other information:

STORAGE AND HANDLING SECTION

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-836-20

Extra Fuerte

tabcin

Dextromethorphan HBr 20 mg / Guaifenesin 400 mg

Expectorant & Cough Suppressant

Expectorante & Supresor de la Tos

  • Cough & Thins and loosens mucus / Tos con flemas
  • Chest & Nasal Congestion / Congestion de pecho y nariz

20 Softgels

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

PDP1PDP1

ESPESP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850043169239GTIN-13: 0850043169239
EAN-13: 0850043169239
GTIN-12: 850043169239
UPC-A: 850043169239
GTIN storage (14 digits): 00850043169239		Tabcin Extra Fuerte w20 Softgel pdp.jpg
QR code linkQR Codeopmx.us/Tabcin Extra Fuerte w20 Softgel pdp.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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-83669729-836-20

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
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SORBITAN6O92ICV9RUIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
POVIDONEFZ989GH94EIACT
SORBITOL SOLUTION8KW3E207O2IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-09-24daily-update2026-09-30 01:02:01
32026-09-07daily-update2026-09-11 03:02:31
22026-01-02full-release2026-06-01 01:31:02

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
5ae83eb4-6c37-6258-e063-6294a90a75ee23223821-4fa0-5d99-e063-6394a90af0e52026-09-07WarningsExact identifier
spl set id: 23223821-4fa0-5d99-e063-6394a90af0e5

Reported adverse events (FAERS/openFDA)#

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