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NDC 69842-0878-08 Pain Reliever fever Reducer 500 mg/15mL Details
Pain Reliever fever Reducer 500 mg/15mL
Pain Reliever fever Reducer is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. 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: 69842-0878-08Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 69842-0878 |
|---|---|
| Product ID | 69842-878_175758e6-6486-46a0-bb42-a0c13d26c002 |
| Associated GPIs | 64200010000914 |
| GCN Sequence Number | 004485 |
| GCN Sequence Number Description | acetaminophen LIQUID 500MG/15ML ORAL |
| HIC3 | H3E |
| HIC3 Description | ANALGESIC/ANTIPYRETICS,NON-SALICYLATE |
| GCN | 16933 |
| HICL Sequence Number | 001866 |
| HICL Sequence Number Description | ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | Pain Reliever fever Reducer |
| Proprietary Name Suffix | Extra Strength |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/15mL |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | CVS Pharmacy |
| 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 69842-0878-08 (69842087808)
| NDC Package Code | 69842-878-08 |
|---|---|
| Billing NDC | 69842087808 |
| Package | 237 mL in 1 BOTTLE, PLASTIC (69842-878-08) |
| Marketing Start Date | 2018-04-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7b5263ad-01b7-4fc5-9384-4da8efe89e35 Details
Uses
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 90 mL (6 tbsp) (3,000 mg) in 24 hours. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks ever day while using this product
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.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Stop use and ask a doctor if
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- new symptoms occur
- redness or swelling is present
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 for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
- do not take more then 4 doses in any 24 hours period
- measure only with dosing cup provided. Do not use any other dosing device
- mL=milliliter
- keep dosing cup with product
- adults and children 12 years and over
- 30 mL every 6 hours while symptoms last
- do not take more than 10 days unless directed by a doctor
- children under 12 years: do not use
Other information
Inactive ingredients
Principal Display Panel
Compare to the active ingredient in Extra Strength Tylenol®*
EXTRA STRENGTH
Acetaminophen, Liquid 500 mg
Pain reliever; Fever reducer
For Ages 12 & over
Cherry flavor
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, PI 02895
CVS.com
INGREDIENTS AND APPEARANCE
| PAIN RELIEVER FEVER REDUCER
EXTRA STRENGTH
acetaminophen liquid |
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| Labeler - CVS Pharmacy (062312574) |