Twkof Children: Package Insert and Label Information

TWKOF CHILDREN- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride and guaifenesin syrup
OPMX LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients (in each 10 mL = 2 teaspoonful)	Purpose
Acetaminophen 325 mg	Pain reliever/fever reducer
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal 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

Age	Dose
Children 6 to under 12 years of age	10 mL or 2 tsp every 4 hours
Children under 6 years of age	do 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 pain reliever/fever reducer, cough suppresant, expectorant, nasal decongestant syrup

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-620 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 10 mL GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg in 10 mL

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM WATER PROPYL GALLATE SUCRALOSE PROPYLENE GLYCOL FD&C RED NO. 40 FD&C BLUE NO. 1 GLYCERIN ANHYDROUS CITRIC ACID SODIUM BENZOATE SORBITOL XANTHAN GUM

Product Characteristics Color purple Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69729-620-06 1 BOTTLE, DISPENSING in 1 CARTON contains a BOTTLE, DISPENSING 1 177 mL in 1 BOTTLE, DISPENSING This package is contained within the CARTON (69729-620-06)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/22/2022

Labeler — OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Operations
SEAWAY PHARMA		117218785	manufacture (69729-620), analysis (69729-620), pack (69729-620)

Revised: 10/2022 OPMX LLC