Label: TUKOL CHILDRENS COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup
- NDC Code(s): 50066-315-04
- Packager: Genomma Lab USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated January 18, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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 acetaminophen.
Allergy alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- 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 accompanied 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 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving 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)
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.
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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=milliliter, tsp=teaspoonful as bulleted statement.
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
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
TUKOL CHILDRENS COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-315 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 32.5 mg in 1 mL Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 1.0 mg in 1 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 20.0 mg in 1 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Sorbitol (UNII: 506T60A25R) Sodium benzoate (UNII: OJ245FE5EU) Sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color BLUE Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-315-04 1 in 1 CARTON 01/17/2023 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/17/2023 Labeler - Genomma Lab USA (832323534)
