Kids' Pain & Fever

SPL v11

SPL

SPL Set ID a7bd0b92-6f85-6175-e053-2995a90ab837

Route

ORAL

Published

Effective Date 2025-04-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Agave Tequilana Juice Water Blueberry

Identifiers & Packaging

Pill Appearance

Color: brown

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-09-13

Description

Drug Facts

Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses

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

the common cold
headache
toothache
flu
sore throat

Dosage and 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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 43683-2

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

Section 44425-7

Other information

store between 20-25°C (68-77°F)

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50568-5

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

Section 50569-3

Ask a doctor before use if your child has liver disease

Section 50570-1

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.

Section 51727-6

Inactive ingredients

oganic agave syrup, organic blueberry flavor, natural flavors, purified water

Section 51945-4

Genexa ^®

MEDICINE MADE CLEAN

Ages 2-11

Kids' Pain & Fever

Acetaminophen

160 mg per 5 mL | Oral Suspension

Pain Reliever

Fever Reducer

Same active ingredient as Children's Tylenol ^®*

0% Artificial Additives

Always free of common allergens, artificial preservatives, flavors, & dyes

Blueberry Flavor

4 fl oz (118 mL)

Section 53413-1

Questions?

1-855-436-3921

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

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

the common cold
headache
toothache
flu
sore throat

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

Drug Facts

Section 43683-2 (43683-2)

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

Section 44425-7 (44425-7)

Other information

store between 20-25°C (68-77°F)

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if your child has liver disease

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients

oganic agave syrup, organic blueberry flavor, natural flavors, purified water

Section 51945-4 (51945-4)

Genexa ^®

MEDICINE MADE CLEAN

Ages 2-11

Kids' Pain & Fever

Acetaminophen

160 mg per 5 mL | Oral Suspension

Pain Reliever

Fever Reducer

Same active ingredient as Children's Tylenol ^®*

0% Artificial Additives

Always free of common allergens, artificial preservatives, flavors, & dyes

Blueberry Flavor

4 fl oz (118 mL)

Section 53413-1 (53413-1)

Questions?

1-855-436-3921

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Advanced Ingredient Data

[{"name": "AGAVE TEQUILANA JUICE", "unii": "GVG8G0207O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "160", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BLUEBERRY", "unii": "253RUG1X1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily reduces fever and relieves minor aches and pains due to: the common cold headache toothache flu sore throat", "34068-7": "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", "34071-1": "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.", "42229-5": "Drug Facts", "43683-2": "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", "44425-7": "Other information store between 20-25°C (68-77°F)", "50565-1": "Keep out of reach of children.", "50566-9": "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.", "50568-5": "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin", "50569-3": "Ask a doctor before use if your child has liver disease", "50570-1": "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.", "51727-6": "Inactive ingredients oganic agave syrup, organic blueberry flavor, natural flavors, purified water", "51945-4": "Genexa ® MEDICINE MADE CLEAN Ages 2-11 Kids' Pain & Fever Acetaminophen 160 mg per 5 mL | Oral Suspension Pain Reliever Fever Reducer Same active ingredient as Children's Tylenol ®* 0% Artificial Additives Always free of common allergens, artificial preservatives, flavors, & dyes Blueberry Flavor 4 fl oz (118 mL)", "53413-1": "Questions? 1-855-436-3921", "55105-1": "Purpose Pain reliever/fever reducer", "55106-9": "Active ingredient (in each 5 mL) Acetaminophen 160 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:10.422695 · Updated: 2026-03-14T23:08:47.595357