INFANTS PAIN AND FEVER CHERRY FLAVOR- acetaminophen suspension

Infants Pain and Fever Cherry Flavor by

Drug Labeling and Warnings

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

Drug Details [pdf]

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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

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

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
  • mL = milliter
  • 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 the 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

STORAGE AND HANDLING

Other information

store between 20-25°C (68-77°F)

do not refrigerate

INACTIVE INGREDIENT

Inactive ingredients

organic agave syrup, organic cherry flavor, natural citrus extract, natural flavor, purified water

QUESTIONS

Questions? 1-855-436-3921

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SHAKE WELL before each use.

Tamper evident: Do not use if perforated band around the bottle is disturbed or missing.

Distributed by: Genexa Inc. | Atlanta, GA 30324

genexa.com | U.S.Patent No. 11,617,795

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Made in the USA with globally sourced ingredients

NDC: 69676-0097-9

PRINCIPAL DISPLAY PANEL

Genexa®

MEDICINE MADE CLEAN

Infants' Pain & Fever

Acetaminophen

160 mg per 5 mL* | Oral Suspension

Pain Reliever

Fever Reducer

Medicine made clean

Same effective active ingredient, but no artificial fillers.

Organic Cherry Flavor

2 fl oz (59 mL)

Use Only Enclosed Syringe

*Same as Genexa Kids' Pain & Fever

INGREDIENTS AND APPEARANCE

INFANTS PAIN AND FEVER CHERRY FLAVOR 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0097
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)
CHERRY (UNII: BUC5I9595W)

Product Characteristics
Color	brown (Light)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0097-9	1 in 1 CARTON	06/14/2024
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	06/14/2024

Labeler - Genexa Inc. (079751024)