FDA.reportPublic FDA data

Twkof Adult

Manufacturer
OPMX LLC | SEAWAY PHARMA
Effective date
2022-11-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:48:24

Label at a glance#

ProductTwkof Adult
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN
Label structure8 sections

Indications and uses

temporarily relieves these common cold and flu symptoms: sinus congestion and pressure minor aches and pains nasal congestion cough sore throat headache temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

do not give more than directed (see Overdose warning) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = mililiter Age Dose adults and children 12 years of age and older 20 mL in dosing cup provided every 4 hours children under 12 years of age do not use

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 20 mL)Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant
Phenylephrine HCl 10 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these common cold and flu symptoms:

  • sinus congestion and pressure
  • minor aches and pains
  • nasal congestion
  • cough
  • sore throat
  • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminaphen
  • 3 or more alcoholic drinks daily while using this product

Allergy alert

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blister
  • rash

If skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists more than 2 days, is accompained or followed by fever, headache, rash, nausea or vomitting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for children under 12 years of age
  • if you are 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

  • liver disease
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sodium restricted diet

When using this product

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts.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

Overdose warning

OVERDOSAGE SECTION

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any sings or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not give more than directed (see Overdose warning)
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • dose as follows or as directed by a doctor
  • mL = mililiter
AgeDose
adults and children 12 years of age and older20 mL in dosing cup provided every 4 hours
children under 12 years of agedo not use

Other information

OTHER SAFETY INFORMATION

  • each 20 mL contaings: sodium 20 mg
  • store between 20-25 °C (68-77 °F)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, disodium EDTA, FD&C yellow No. 10, FD&C blue No. 1, glycerin, menthol, propylene gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Questions?

OTC - QUESTIONS SECTION

Call 619-600-5632 MON to FRI, 9 a.m. to 6 p.m. PTZ

Twkof Adult 6 fl oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-621-06 Tkof Adult 6 fl oz Twkof_Adult_6fl_ozTwkof_Adult_6fl_oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-621-062024-04-05C16284748780-11030e365-45e3-111a-e063-dadaa90a10e2Twkof Adult - 6 fl oz
69729-621-062024-01-30C16284748780-11030e365-45e3-111a-e063-dadaa90a10e2Twkof Adult - 6 fl oz

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-62169729-621-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT
PROPYL GALLATE8D4SNN7V92IACT
SUCRALOSE96K6UQ3ZD4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
GUAIFENESIN495W7451VQACTIB
EDETATE DISODIUM7FLD91C86KIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT

Source Document#

Source XML

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
155c8f38-e6d2-a98c-e063-6394a90a0954dd7d3675-9c89-580c-e053-2a95a90af7a82024-04-05WarningsExact identifier
spl set id: dd7d3675-9c89-580c-e053-2a95a90af7a8

Reported adverse events (FAERS/openFDA)#

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