NDC | 50066-519-24 |
Set ID | 85fe6f0f-41c8-44d3-a34a-355938da5f72 |
Category | HUMAN OTC DRUG LABEL |
Packager | Genomma Lab USA, Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Drug FactsActive ingredients(in each 10 mL = 2 teaspoonful)
- Purpose
- Uses
-
Warnings
Liver warning: This product cantains acetaminophen. Severe liver damage may occur if your child takes
- more tha 5 doses in 24 hours which is the maxium 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 non prescription). If you are not sure whether a drug containd 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 an MAOI drug. If you do not know if ask a doctor or pharmacist beforre giving this product.
- Ask a doctor before use if the child has
- Ask a doctor or pharmacist before use if the child is
- When using this product
-
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
- 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
-
Directions
-
do not give more than directed
(see Overdose warning) - product not labeled with directions for adult use
- do not give more than 5 doses in any 24-hour period
- do not give for 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
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
-
do not give more than directed
- Other information
- Inactive ingredients
- Questions?
-
Children's Tukol Multi-Symptom Cold & Flu product label
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Children's Tukol®
Acetaminophen/Guaifenesin/Dextromethorphan HBr/Phenylephrine HCL
Pain Reliever/Fever Reducer/Expectorant/Cough Suppressant/Nasal CongestionNEW!
Multi-Symptom Cold & Flu
Ages 6-11
Fever•Sore Throat•
Stuffy Nose
Cough•PhlegmBERRY flavor
4 FL OZ (118 mL)
Distributed By
Genomma Lab USA Inc. Houston, TX 77027BX-057
Lot:
Exp:
-
INGREDIENTS AND APPEARANCE
CHILDRENS TUKOL MULTI-SYMPTOM COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-519 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-519-24 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/04/2016 Labeler - Genomma Lab USA, Inc. (832323534) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(50066-519)