Dolex Suspension
FDA Label NDC 55758-026
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Dolex (NDC 55758-026). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient & purpose, otc - purpose, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredient (in each 5 mL = 1 teaspoonful) | Purpose |
| Acetaminophen 160 mg | Pain reliever/ fever reducer |
Uses
temporarily
- reduces fever
- the common cold
- flu
- headache
- sore throat
- toothache
relieves minor aches and pains due to:
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 other 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 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.
Keep out of reach of children.
Overdose Warning:
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away at 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.
Directions
- this product does not contain directions or complete warnings for adult use
- shake well before using
- use only enclosed dosing cup. Do not use any other dosing device
- mL = milliliter; tsp = teaspoonful
- find the right dose on the chart below. If possible, use weight to dose, otherwise, use age.
- if needed, 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 (mL or tsp)* |
| under 24 | undere 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL (1 tsp) |
| 36-47 | 45-5 years | 7.5 mL (1 1/2 tsp) |
| 48-59 | 6-8 years | 10 mL (2 tsps) |
| 60-71 | 9-10 years | 12.5 mL (2 1/2 tsps) |
| 72-95 | 11 years | 15 mL (3 tsps) |
*or as directed by a doctor
Other Information
- each 5 mL (1 tsp) contains: sodium 3 mg
- store between 68-77° F (20-25° C)
- do not refrigerate
- keep carton for full directions for use
Inactive Ingredients
anhydrous citric acid, FD&C Blue #1, FD&C Red #40, flavor, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose
Questions?
1-877-798-5944 (9 AM - 5 PM EST) or pharmadel.com
** This product is not manufactured or distributed by Mcneil Consumer Healthcare, distributor of Children’s Tylenol® Oral Suspension.
Distributed By:
PHARMADEL LLC.
New Castle, DE 19720
Principal Display Panel
4 FL OZ (118 mL)
Ages 2 to 11
* Please review the disclaimer below.