Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Childrens Pain Relief Dye-free (NDC 67091-119). 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 (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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 160 mg
Pain reliever/fever reducer
Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes:
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.
liver disease
liver disease
taking the blood thinning drug warfarin
taking the blood thinning drug warfarin
do not exceed recommended dose (see overdose warning)
do not exceed recommended dose (see Overdose warning).
These could be signs of a serious condition.
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.
| 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
butylparaben, microcrystalline cellulose, carboxymethylcellulose sodium, citric acid,flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sorbitol,sucralose, xanthan gum
Call 800-824-1706 Monday - Friday 9am - 4 pm MST
**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
* Please review the disclaimer below.