KIDS PAIN AND FEVER- acetaminophen liquid

Kids Pain and Fever by

Drug Labeling and Warnings

Kids Pain and Fever by is a Otc medication manufactured, distributed, or labeled by Genexa Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

PURPOSE

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses
temporarily reduces fever and relieves minor aches and pains due to:

• the common cold
• headache
• toothache
• flu
• sore throat

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.

Ask a doctor before use if your child has liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Stop use and ask a doctor if

• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

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 EACH USE
• 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

Other information

store between 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

agave syrup (organic), blueberry flavor (organic), flavors (natural), purified water

QUESTIONS

Questions?

1-855-436-3921

SPL UNCLASSIFIED SECTION

*When compared to the ingredient profiles in the leading brand's top-selling comparable products. (FRC2025)

SHAKE WELL BEFORE EACH USE

DO NOT use if perforated band around the bottle seal is disturbed or missing.

Made in the USA with globally sourced ingredients

Distributed by: Genexa Inc., Atlanta, GA 30324

genexa.com

NDC: 69676-0041-9

PRINCIPAL DISPLAY PANEL

Pediatrician Preferred #1 INGREDIENTS*

Genexa ®

CLEAN MEDICINE

Ages 2-11

Kids' Pain Reliever & Fever Reducer

Acetaminophen

160 mg per 5 mL / Oral Suspension

0% Artificial Additives, Dyes, Artificial Sweeteners, Common Allergens

Made with Real Agave + Blueberry Flavoring

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

KIDS PAIN AND FEVER 
acetaminophen liquid

Product 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
WATER (UNII: 059QF0KO0R)
BLUEBERRY (UNII: 253RUG1X1A)
AGAVE TEQUILANA JUICE (UNII: GVG8G0207O)

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	03/06/2025
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)