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NDC 72189-0197-30 acetaminophen 325 mg/1 Details
acetaminophen 325 mg/1
acetaminophen is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by DIRECT RX. 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: 72189-0197-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 72189-0197 |
|---|---|
| Product ID | 72189-197_d9cb1c58-4df1-7fe4-e053-2995a90a2dce |
| Associated GPIs | 64200010000310 |
| 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 | n/a |
| Non-Proprietary Name | acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 325 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | DIRECT RX |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 72189-0197-30 (72189019730)
| NDC Package Code | 72189-197-30 |
|---|---|
| Billing NDC | 72189019730 |
| Package | 30 TABLET in 1 BOTTLE (72189-197-30) |
| Marketing Start Date | 2021-04-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c10b207e-27df-ea5e-e053-2995a90a8db4 Details
SPL UNCLASSIFIED SECTION
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every 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 non prescription). 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 the user has liver disease.
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.
Stop use and ask a doctor if
pain gets worse or lasts more than 10 days in adults
pain gets worse or lasts more than 5 days in children under 12 years
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: 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 for adults as well as for children even if you do not notice any signs or symptoms.
SPL UNCLASSIFIED SECTION
Directions
do not take more than directed (see overdose warning)
adults and children 12 years and over
take 2 tablets every 4 to 6 hours while symptoms last
do not take more than 10 tablets in 24 hours, unless directed by a doctor
do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years
take 1 tablet every 4 to 6 hours, while symptoms last
do not take more than 5 tablets in 24 hours
do not use for more than 5 days unless directed by a doctor
children under 6 years ask a doctor
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INGREDIENTS AND APPEARANCE
| ACETAMINOPHEN
acetaminophen tablet |
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| ACETAMINOPHEN
acetaminophen tablet |
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| Labeler - DIRECT RX (079254320) |
| Registrant - DIRECT RX (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| DIRECT RX | 079254320 | repack(72189-197, 72189-247) | |