Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Kids Pain and Fever
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
VALUE 2-PACK
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 asChildren’s Tylenol****®*
0% Artificial Additives
Always free of common allergens, artificial preservatives, flavors, & dyes
TWO - 4 FL OZ (118 mL) BOTTLES
TOTAL - 8 FL OZ (236 mL)
Cherry Flavor
RECENT MAJOR CHANGES SECTION
INDICATIONS & USAGE SECTION
Uses
temporarily reduces fever and relieves minor aches and pains due to:
- the common cold
- headache
- toothache
- flu
- sore throat
DOSAGE & ADMINISTRATION SECTION
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 |
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 SECTION
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 usewith 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.
STORAGE AND HANDLING SECTION
Other information
store between 20-25°C (68-77°F)
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
OTC - QUESTIONS SECTION
Questions?
1-855-436-3921
SPL UNCLASSIFIED SECTION
SHAKE WELL BEFORE EACH USE
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
INACTIVE INGREDIENT SECTION
Inactive ingredients
organic agave syrup, organic cherry flavor, natural flavors, purified water