FDA Label for Childrens Pain Relief Dye-free
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML)
- 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
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Childrens Pain Relief Dye-free Product Label
The following document was submitted to the FDA by the labeler of this product Winco Foods, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes:
- more than 5 doses in 24 hours, which is maximum daily amount
- with other drugs containing acetaminophen
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severeskin reactions. Symptoms may include:
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, or 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 non prescription). If you are not sure whether a drug contain acetaminophen, ask a doctor or pharmacist drugs.
- 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
liver disease
Ask A Doctor Or Pharmacist Before Use If Your Child Is
taking the blood thinning drug warfarin
taking the blood thinning drug warfarin
When Using This Product
do not exceed recommended dose (see overdose warning)
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
- redness or swelling is present
- new symptoms occur
- These could be signs of a serious condition.
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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 (1-800-222-1222) right away. Quick medical attention is critical even if if you do not notice any signs or symptoms.
Directions
- this product does not contain directions or complete warnings for adult dose
- do not take more than directed (see Overdose warning)
- shake well before using
- mL = milliliter
- use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
Weight (lb) | Age (year) | Dose (mL)* |
under 24 lbs | under 2 years | ask a doctor |
24-35 lbs | 2-3 | 5 mL |
36-47 lbs | 4-5 | 7.5 mL |
48 - 59 lbs | 6-8 | 10 mL |
60 - 71 lbs | 9-10 | 12.5 mL |
72 - 95 lbs | 11 years | 15 mL |
*or as directed by a doctor
Other Information
- each 5 mL contains: sodium 2 mg
- store between 20-25oC(68-77oF)
- do not refrigerate
- see bottom panel for lot number and expiration date
Inactive Ingredients
butylparaben, microcrystalline cellulose, carboxymethylcellulose sodium, citric acid,flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sorbitol,sucralose, xanthan gum
Questions?
Call 800-824-1706 Monday - Friday 9am - 4 pm MST
Principal Display Panel
**Compare to the active ingredient in Children's TYLENOL® Oral Suspension
ORAL SUSPENSION
Pain Relief
Children's
ACETAMINOPHEN 160 mg per 5 mL /
PAIN RELIEVER - FEVER REDUCER
Alcohol Free
Aspirin & Inuprofen Free
For Ages 2-11 Years
Dye Free
Grape Flavor
FL OZ (mL)
**This product is not manufactured or distributed by McNEIL CONSUMER HEALTHCARE, distributor of Children's TYLENOL® Oral Suspension.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AMD PRODUCT INFORMATION.
DISTRIBUTED BY: WINCO FOODS, LLC BOISE, ID 83704
Comments or Question?
800-824-1706 www.wincofoods.com
Package Label
WINCO FOODS Children's Pain Relief Dye Free Grape Flavor
* Please review the disclaimer below.