Non-Aspirin
Quality Choice 44-449 Childrens Delisted
ea786813-87ee-441d-815b-352aa126744a
HUMAN OTC DRUG LABEL
Aug 26, 2025
CHAIN DRUG MARKETING ASSOCIATION INC
DUNS: 011920774
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal display panel
QC®
** QUALITY**
** CHOICE**
NDC 63868-186-24
**Compare to the
Active Ingredient in
Children’s Tylenol®
Children's
NON-ASPIRIN
Acetaminophen 160 mg
****Chewable Tablets
Pain Reliever / Fever Reducer
Ages 2-11
Pain/Fever
Ibuprofen Free
Aspirin Free
Chew or crush tablets
completely before swallowing.
Grape
Flavor
actual size
24 CHEWABLE TABLETS
TAMPER EVIDENT: DO NOT USE IF
** IMPRINTED SAFETY SEAL UNDER**
** CAP IS BROKEN OR MISSING**
Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
SATISFACTION GUARANTEED
** 100% QC®**
**This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Children’s Tylenol®.
50844 REV0522B44908

Quality Choice 44-449
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
- headache
- sore throat
- flu
- toothache
- the common cold
- temporarily reduces fever
OTC - QUESTIONS SECTION
Questions or comments?
1-800-426-9391
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each chewable tablet)
Acetaminophen 160 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
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 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.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
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 dosage.
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.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
*this product does not contain directions or complete warnings for adult use *do not give more than directed
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor
Weight (lb) |
Age (yr) |
Dose (chewable tablets)* |
Under 24 |
Under 2 |
Ask a doctor |
24-35 |
2-3 |
1 tablet |
36-47 |
4-5 |
1 1/2 tablets |
48-59 |
6-8 |
2 tablets |
60-71 |
9-10 |
2 1/2 tablets |
72-95 |
11 |
3 tablets |
*or as directed by a doctor
STORAGE AND HANDLING SECTION
Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid high humidity
- see end flap for expiration date and lot number
INACTIVE INGREDIENT SECTION
Inactive ingredients
citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose