Label: KIDS PAIN AND FEVER- acetaminophen liquid
- NDC Code(s): 69676-0041-3, 69676-0041-9
- Packager: Genexa Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 7, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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 a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, 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.
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DOSAGE & ADMINISTRATION
Directions
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see Overdose warning)
- SHAKE WELL BEFORE USING
- find right dose on chart below
- for accurate dosing, use measuring cup provided.
- Do not use with any other dosing device.
- give dose every 4 hours while symptoms last
- if possible, use weight to dose; otherwise, use age
- do not give more than 5 times in 24 hours
Weight Use Age Dose under 24 lbs. under 2 years ask a doctor 24-35 lbs. 2-3 years 5 mL 36-47 lbs. 4-5 years 7.5 mL 48-59 lbs. 6-8 years 10 mL 60-71 lbs. 9-10 years 12.5 mL 72-95 lbs. 11 years 15 mL - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
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SPL UNCLASSIFIED SECTION
Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.
Certified B Corporation
CERTIFIED GLUTEN FREE GFCO.ORG
CERTIFIED VEGAN VEGAN.ORG
Distributed by: Genexa Inc., Atlanta, GA 30324
genexa.com | U.S. Patent No. 11,617,795
*This product is not manufactured or distributed by Johnson & Johnson Corp., owner of the registered trademark Children's Tylenol® Oral Suspension Grape.
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
Genexa®
MEDICINE MADE CLEAN
Ages 2-11
Kids' Pain & Fever
Acetaminophen
160 mg per 5 mL | Oral Suspension
Pain Reliever Fever ReducerMade with the same active ingredient as Children's Tylenol® Oral Suspension Grape*
Medicene made clean
Same effective active ingredient, but no artificial fillers.
Organic Blueberry Flavor
4 FL OZ (118 mL) Dosing cup included
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INGREDIENTS AND APPEARANCE
KIDS PAIN AND FEVER
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69676-0041 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 AGAVE TEQUILANA JUICE (UNII: GVG8G0207O) WATER (UNII: 059QF0KO0R) CITRUS FRUIT (UNII: XDK00Z8012) BLUEBERRY (UNII: 253RUG1X1A) Product Characteristics Color brown (Golden) Score Shape Size Flavor BLUEBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69676-0041-9 1 in 1 CARTON 09/13/2023 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:69676-0041-3 5 mL in 1 POUCH; Type 0: Not a Combination Product 09/13/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/13/2023 Labeler - Genexa Inc. (079751024)