Twkof Adult by OPMX LLC / SEAWAY PHARMA Twkof Adult - 6 fl oz

Twkof Adult by

Drug Labeling and Warnings

Twkof Adult by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, SEAWAY PHARMA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TWKOF ADULT- pain reliever/fever reducer, cough suppresant, expectorant, nasal decongestant syrup 
OPMX LLC

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Twkof Adult - 6 fl oz

Drug Facts

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

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

Liver warning

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

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

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

  • 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

  • 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

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

When using this product

do not use more than directed

Stop use and ask a doctor if

  • 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

ask a health professional before use.

Keep out of reach of children

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 right away. Quick medical attention is critical even if you do not notice any sings or symptoms.

Directions

  • 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

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

Inactive ingredients

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?

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

Twkof Adult 6 fl oz

NDC: 69729-621-06 Tkof Adult 6 fl oz Twkof_Adult_6fl_oz

TWKOF ADULT 
pain reliever/fever reducer, cough suppresant, expectorant, nasal decongestant syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69729-621
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69729-621-061 in 1 CARTON04/22/202212/31/2023
1177 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/22/202212/31/2023
Labeler - OPMX LLC (029918743)
Establishment
NameAddressID/FEIBusiness Operations
SEAWAY PHARMA117218785manufacture(69729-621) , analysis(69729-621) , pack(69729-621)

Revised: 4/2024

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