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NDC 61919-0860-71 ACETAMINOPHEN 650 mg/1 Details
ACETAMINOPHEN 650 mg/1
ACETAMINOPHEN is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by DirectRX. 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: 61919-0860-71Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 61919-0860 |
|---|---|
| Product ID | 61919-860_876fef38-0ec9-e076-e053-2a95a90a3565 |
| Associated GPIs | 64200010000420 |
| 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 | ACETAMINOPHEN |
| Proprietary Name Suffix | ER |
| Non-Proprietary Name | ACETAMINOPHEN |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 650 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | DirectRX |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076200 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 61919-0860-71 (61919086071)
| NDC Package Code | 61919-860-71 |
|---|---|
| Billing NDC | 61919086071 |
| Package | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-860-71) |
| Marketing Start Date | 2019-04-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 876fef38-0ec8-e076-e053-2a95a90a3565 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
•
more than 6 caplets in 24 hours, which is the maximum daily amount
•
with other drugs containing acetaminophen
•
3 or more alcoholic drinks every day while using this product
Allergy alert
acetaminophen may cause severe skin reactions. Symptoms may include:
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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.
•
if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a doctor before use if you have liver disease.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Stop use and ask a doctor if
•
pain gets worse or lasts more than 10 days
•
fever gets worse or lasts more than 3 days
•
new symptoms occur
•
redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
SPL UNCLASSIFIED SECTION
do not take more than directed (see overdose warning)
adults
•
take 2 caplets every 8 hours with water
•
swallow whole; do not crush, chew, split or dissolve
•
do not take more than 6 caplets in 24 hours
•
do not use for more than 10 days unless directed by a doctor
under 18 years of age
•
ask a doctor
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| ACETAMINOPHEN
ER
acetaminophen tablet, film coated, extended release |
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| Labeler - DirectRX (079254320) |
| Registrant - DirectRX (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| DirectRX | 079254320 | relabel(61919-860) | |