FDA.reportPublic FDA data

Twkof Children

Manufacturer
OPMX LLC | SEAWAY PHARMA
Effective date
2022-10-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:51:24

Label at a glance#

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

Indications and uses

temporarily relieves these common cold and flu symptoms: nasal decongestion cough minor aches and pains sorethroat 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) product not labeled with directions or warnings for adult use do not give more than 5 doses in any 24-hour period do not give more than 5 days unless directed by a doctor measure only with dosing cup provided dose as follows or as directed by a doctor mL = mililiter; tsp = teaspoonful Age Dose Children 6 to under 12 years of age 10 mL or 2 tsp every 4 hours Chi...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 10 mL = 2 teaspoonful)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these common cold and flu symptoms:

  • nasal decongestion
  • cough
  • minor aches and pains
  • sorethroat
  • 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 your child takes:

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminaphen

Allergy warning

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 aceptaminophen (prescription or nonprescription). I f you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • for a child who is 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 the child has

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

the child is taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occur
  • redness or swelling is present
  • pain, nasal congestion or cough gets worse or lasts more than 5 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • cough comes back, or occurs with rash or headache that lasts

These could be signs of a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any sings or symptoms.

Overdose warning

SPL UNCLASSIFIED 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 (1-800-222-1222) 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)
  • product not labeled with directions or warnings for adult use
  • do not give more than 5 doses in any 24-hour period
  • do not give more than 5 days unless directed by a doctor
  • measure only with dosing cup provided
  • dose as follows or as directed by a doctor
  • mL = mililiter; tsp = teaspoonful
AgeDose
Children 6 to under 12 years of age10 mL or 2 tsp every 4 hours
Children under 6 years of agedo not use

Other information

OTHER SAFETY INFORMATION

  • each 10 mL contaings : sodium 6 mg
  • store between 20-25 °C (68-77 °F). Do not refrigerate
  • dosing cup provided
  • keep carton for complete Drug facts

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, EDTA Disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, propylene gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

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

Twkof - Children 177 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 69729-629-06 - Twof Children 177 mL

Twkof_Children_6fl_ozTwkof_Children_6fl_oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-620-062024-04-05C16284748780-11030e365-53a4-111a-e063-dadaa90a10e2Twkof - Children 6 fl oz
69729-620-062024-01-30C16284748780-11030e365-53a4-111a-e063-dadaa90a10e2Twkof - Children 6 fl oz

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-62069729-620-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
PROPYL GALLATE8D4SNN7V92IACT
SUCRALOSE96K6UQ3ZD4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
FD&C RED NO. 40WZB9127XOAIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GUAIFENESIN495W7451VQACTIB
GLYCERINPDC6A3C0OXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT

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
155ca669-a441-9c2a-e063-6394a90a5a99dd4202b4-cbff-64b9-e053-2995a90aeb972024-04-05WarningsExact identifier
spl set id: dd4202b4-cbff-64b9-e053-2995a90aeb97

Reported adverse events (FAERS/openFDA)#

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