Label: CHILDRENS TUKOL ACETAMINOPHEN FEVER REDUCER PAIN REDUCER- acetaminophen liquid
- NDC Code(s): 50066-525-24
- Packager: Genomma Lab USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 April 15, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug FactsActive ingredient(in each 5 mL = 1 teaspoonful)
- Purpose
- Uses
-
Warnings
Liver warning: This product cantains acetaminophen. Severe liver damage may occur if your child takes
- more than 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
- 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
- Keep out of reach of children.
- Overdose warning:
-
Directions *
- product is not labeled with directions or complete warning for adult use
- Shake well before using
- 1mL = milliliter; tsp = teaspoonful
- find the right dose on chart below. If posssible, use weight to dose: otherwise use age.
- if needed, repeat dose every 4 hours while symptons last
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor
weight (lb) age dose (mL or tsp)
under 24 under 2 years ask a doctor
24 - 35 2 - 3 years 5 mL (1 tsp)
36- 47 4 - 5 years 7.5 mL (1 1/2 tsp)
48 - 59 6 - 8 years 10 mL (10 mL (2 tsp)
60- 71 9 - 10 years 12.5 mg (2 1/2 tsp)
72 95 11 years 15 mL (3 tsp)
use only enclosed dosing cup specfically designed for use with this product
- Attention:
- Other information
- Inactive ingredients
- Questions?
- Children's Tukol® Fever Pain product label
-
INGREDIENTS AND APPEARANCE
CHILDRENS TUKOL ACETAMINOPHEN FEVER REDUCER PAIN REDUCER
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-525 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BUTYLPARABEN (UNII: 3QPI1U3FV8) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-525-24 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/03/2016 Labeler - Genomma Lab USA, Inc. (832323534) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(50066-525)
