Fast Acting
Crossing well Health Pedia Care Pain + Fever Drug Facts
e069060f-fbb2-4c7a-b872-00b3ab86d01b
HUMAN OTC DRUG LABEL
Aug 13, 2025
Randob Labs., Ltd.
DUNS: 061995007
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 (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
NDC 52412-912-01
Fast Acting
Pedia Care®
100% dedicated to kids™
Infants
ACETAMINOPHEN
Pain Reliever / Fever Reducer
Acetaminophen (160mg per 5 mL)
Oral Suspension
- No Added Alcohol
- Ibuprofen Free
- Aspirin Free
- No Parabens
Natural Grape Flavor
(Use only Enclosed Syringe)
1FL OZ (30mL)
160 mg per 5 mL
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING
IMPORTANT: Keep this carton for future reference on full labeling.
Package Label of 1 FLOZ (30 mL)
Package Label of 4 FLOZ (118 mL)
INDICATIONS & USAGE SECTION
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
INACTIVE INGREDIENT SECTION
Inactive ingredients
anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, sodium benzoate, purified water, sodium citrate dihydrate, sorbitol liquid, sucralose, xanthan gum
OTC - QUESTIONS SECTION
Questions?
1-866-467-2748
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 5 mL)
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 hasliver disease
Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin
When using this product do not exceed recommended dose (seeoverdose 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) Quick 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 (seeoverdose warning)** *shake well before using
- mL = milliliter
- find right dose on chart. If possible, use weight to dose; otherwise, use age.
- remove the child protective cap and squeeze your child’s dose into the dosing cup
- do not give more than 5 times in 24 hours
Weight (lb) |
Age (yr) |
Dose (mL)** |
Under 24 |
Under 2 years |
Ask a doctor |
24 – 35 |
2 – 3 years |
5 mL |
36 – 47 |
4 – 5 years |
7.5 mL |
48 – 59 |
6 – 8 years |
10 mL |
60 – 71 |
9 – 10 years |
12.5 mL |
72 – 95 |
11 years |
15 mL |
**or as directed by a doctor
**Attention:**use only enclosed dosing cupl specifically designed for use with this product.
Do not use any other dosing device.
STORAGE AND HANDLING SECTION
Other information
- very low sodium
- store at room temperature