Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
Dye Free Pain Reliever Suspension
FDA Label NDC 21130-285
16 label sections · Submitted to the FDA by Safeway, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway, Inc. for the product Dye Free Pain Reliever (NDC 21130-285). 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.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
- temporarily reduces fever
- temporarily 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 your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin 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, 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 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 (see overdose warning)
Stop Use And Ask A Doctor If
- 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 (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
- this product does not contain directions or complete warnings for adult use
- do not take more than directed (see overdose warning)
- shake well before using
- mL = milliliter
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- 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
| Weight (lb) | Age (year) | Dose (mL)* |
| under 24 | under 2 | ask a doctor |
| 24-35 | 2-3 | 5 mL |
| 36-47 | 4-5 | 7.5 mL |
| 48-59 | 6-8 | 10 mL |
| 60-71 | 9-10 | 12.5 mL |
| 72-95 | 11 | 15 mL |
*or as directed by a doctor
Other Information
- each 5 mL contains:sodium 2 mg
- store between 20-25°C (68-77°F)
- do not refrigerate
- see bottom panel for lot number and expiration date
Inactive Ingredients
butylparaben, carboxymethylcellulose sodium, citric acid, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
Call 1-888-723-3939 Monday-Friday 7AM-6PM PST
Principal Display Panel
FOR AGES 2-11 YEARS
Children's Dye-Free Pain Reliever
Acetaminophen 160 mg per 5 mL
Pain Reliever / Fever Reducer
Oral Suspension
- Alcohol free
- Aspirin free
- Ibuprofen free
- Dosage cup included
GRAPE FLAVOR
FL OZ (mL)
**Compare to Children's Tylenol® Oral Suspension active ingredient
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral suspension.
DISTRIBUTED BY:
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
Product Label
SIGNATURE CARE Children's Dye-Free Pain Reliever Grape Flavor
* Please review the disclaimer below.
