Infants' Pain & Fever Cherry Flavor

Infants' Pain & Fever Cherry Flavor
SPL v2
SPL
SPL Set ID 19215ea7-d55f-8d81-e063-6294a90a4924
Route
ORAL
Published
Effective Date 2025-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Agave Tequilana Juice Water Cherry

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-20

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
    • mL = milliliters
    • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • push air out of syringe. Insert syringe tip into the bottle opening
    • flip bottle upside down. Pull white part of syringe to the correct dose
    • dispense liquid slowly into child's mouth, toward inner cheek
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    • replace cap tightly to maintain child-resistant packaging

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Weight Age Dose
under 24 lbs under 2 years ask a doctor
24-35 lbs. 2-3 years 5 mL

Description

Drug Facts

Section 34088-5

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.

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
  • mL = milliliters
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • push air out of syringe. Insert syringe tip into the bottle opening
  • flip bottle upside down. Pull white part of syringe to the correct dose
  • dispense liquid slowly into child's mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • replace cap tightly to maintain child-resistant packaging

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Weight Age Dose
under 24 lbs. under 2 years ask a doctor
24-35 lbs. 2-3 years 5 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 50567-7

When using this product do not exceed recommended dose (see overdose warning)

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

organic agave syrup, organic cherry flavor, natural flavors, purified water

Section 51945-4

Genexa ®

MEDICINE MADE CLEAN

Infants' Pain & Fever

Acetaminophen

160 mg per 5 mL* | Oral Suspension

Pain Reliever

Fever Reducer

Same active ingredient as Infants' Tylenol ®†

0% Artificial Additives

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

2 fl oz (59 mL)

*Same as Genexa Kids' Pain & Fever

Cherry Flavor

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
    • mL = milliliters
    • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • push air out of syringe. Insert syringe tip into the bottle opening
    • flip bottle upside down. Pull white part of syringe to the correct dose
    • dispense liquid slowly into child's mouth, toward inner cheek
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    • replace cap tightly to maintain child-resistant packaging

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Weight Age Dose
under 24 lbs under 2 years ask a doctor
24-35 lbs. 2-3 years 5 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 34088-5 (34088-5)

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.

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
  • mL = milliliters
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • push air out of syringe. Insert syringe tip into the bottle opening
  • flip bottle upside down. Pull white part of syringe to the correct dose
  • dispense liquid slowly into child's mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • replace cap tightly to maintain child-resistant packaging

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Weight Age Dose
under 24 lbs. under 2 years ask a doctor
24-35 lbs. 2-3 years 5 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 50567-7 (50567-7)

When using this product do not exceed recommended dose (see overdose warning)

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

organic agave syrup, organic cherry flavor, natural flavors, purified water

Section 51945-4 (51945-4)

Genexa ®

MEDICINE MADE CLEAN

Infants' Pain & Fever

Acetaminophen

160 mg per 5 mL* | Oral Suspension

Pain Reliever

Fever Reducer

Same active ingredient as Infants' Tylenol ®†

0% Artificial Additives

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

2 fl oz (59 mL)

*Same as Genexa Kids' Pain & Fever

Cherry Flavor

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


Raw Label Data

All Sections (JSON)