Search by Drug Name or NDC
NDC 63868-0836-60 Pain Relief 160 mg/5mL Details
Pain Relief 160 mg/5mL
Pain Relief is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). 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: 63868-0836-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 63868-0836 |
|---|---|
| Product ID | 63868-836_42528c30-cfec-46e2-a6d4-4b553bead55b |
| Associated GPIs | |
| GCN Sequence Number | 016947 |
| GCN Sequence Number Description | acetaminophen ORAL SUSP 160 MG/5ML ORAL |
| HIC3 | H3E |
| HIC3 Description | ANALGESIC/ANTIPYRETICS,NON-SALICYLATE |
| GCN | 26911 |
| HICL Sequence Number | 001866 |
| HICL Sequence Number Description | ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | Pain Relief |
| Proprietary Name Suffix | Infants |
| 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 | QUALITY CHOICE (Chain Drug Marketing Association) |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | n/a |
Package
Package Images
NDC 63868-0836-60 (63868083660)
| NDC Package Code | 63868-836-60 |
|---|---|
| Billing NDC | 63868083660 |
| Package | 1 BOTTLE in 1 BOX (63868-836-60) / 59 mL in 1 BOTTLE |
| Marketing Start Date | 2015-05-31 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.06218 |
| Pricing Unit | ML |
| Effective Date | 2022-08-17 |
| NDC Description | QC INFANT PAIN RLF 160 MG/5 ML |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-08-17 |
Standard Product Labeling (SPL)/Prescribing Information SPL 111931c9-b2ba-49c1-b2a6-bb978d85822e Details
Uses
Warnings
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddenings
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetamnophen. 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
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 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 the right dose on chart below. If possible, use weight to dose; otherwise, use age
- only use the enclosd syringe.
Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
- remove cap and insert syringe into hole at top of bottle and turn upside down.
- pull back syringe until filled to the prescribed level. if you pass the prescribed level, simply push syringe back until you have reached the desired level.Slowly dispense the liquid into your child's mouth (towards inner cheek).
- if needed, repeat dose every 4 hours while symptoms last.
- do not use give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor
- replace cap tightly to maintain child resistance
| Weight (lb) | Age (yr) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years |
5 mL |
*or as directed by a doctor
Other information
Inactive ingredients
Principal Display Panel
**Compare to active ingredient in Infanus' Tylenol® Oral Suspension
Infants' Pain Relief
Oral Suspension
Acetaminophen 160mg per 5 mL
Pain Reliever & Fever Reducer
Alcohol free
Aspirin free
Ibuprofen free
Ages 2-3 years
FL OZ (mL)
Grape flavor
Use Only Enclosed Syringe
**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Infants' Tylenol® Oral Suspension.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR PRINTED SAFETY SEAL AROUND THE BOTTLE IS BROKEN OR MISSING.
Distributed by C.D.M.A., Inc.©
43157 W.Nine Mile
Novi, MI 48376-0995
INGREDIENTS AND APPEARANCE
| PAIN RELIEF
INFANTS
acetaminophen suspension |
||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
| Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774) |