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

Twkof Children by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

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Twkof - Children 6 fl oz

Drug Facts

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

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

Liver warning

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

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 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

  • 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

the child is taking the blood thinning drug warfarin

When using this product

do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

  • 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

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

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

  • 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

  • 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

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?

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

Twkof - Children 177 mL

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

Twkof_Children_6fl_oz

TWKOF CHILDREN 
pain reliever/fever reducer, cough suppresant, expectorant, nasal decongestant syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69729-620
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
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)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69729-620-061 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(69729-620) , analysis(69729-620) , pack(69729-620)

Revised: 4/2024

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