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NDC 00363-0283-04 Dye Free Pain and Fever 160 mg/5mL Details
Dye Free Pain and Fever 160 mg/5mL
Dye Free Pain and Fever is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. The primary component is ACETAMINOPHEN.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 00363-0283-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 00363-0283 |
|---|---|
| Product ID | 0363-0283_b8557c1e-56b5-4b15-b204-732e22da8fa0 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Dye Free Pain and Fever |
| Proprietary Name Suffix | Childrens |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 160 |
| Active Ingredient Units | mg/5mL |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | Walgreens |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00363-0283-04 (00363028304)
| NDC Package Code | 0363-0283-04 |
|---|---|
| Billing NDC | 00363028304 |
| Package | 1 BOTTLE, PLASTIC in 1 BOX (0363-0283-04) / 118 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2015-03-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d Details
Uses
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 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
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 (1-800-222-1222) right away. 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
- use only the enclosed dosing cup designed for 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.
*or as 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 |
Other information
Inactive ingredients
Principal Display Panel
Compare to the active ingredient in Children's Tylenol® Oral Suspension††
Children's
Dye-Free
Pain & Fever
ACETAMINOPHEN 160 mg PER 5 mL
PAIN RELIEVER /
FEVER REDUCER
ORAL SUSPENSION
Aspirin Free
Alcohol Free
Ibuprofen Free
AGES 2-11 YEARS
FL OZ (mL)
Bubble Gum
DOSAGE CUP PROVIDED
††This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral suspension.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
INGREDIENTS AND APPEARANCE
| DYE FREE PAIN AND FEVER
CHILDRENS
acetaminophen suspension |
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| Labeler - Walgreens (008965063) |