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NDC 00404-0716-13 Henry Schein Acetaminophen 500 mg/1 Details
Henry Schein Acetaminophen 500 mg/1
Henry Schein Acetaminophen is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Henry Schein, Inc.. 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: 00404-0716-13Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 00404-0716 |
|---|---|
| Product ID | 0404-0716_da431097-9d76-dfe0-e053-2a95a90ad917 |
| Associated GPIs | 64200010000315 |
| GCN Sequence Number | 004490 |
| GCN Sequence Number Description | acetaminophen TABLET 500 MG ORAL |
| HIC3 | H3E |
| HIC3 Description | ANALGESIC/ANTIPYRETICS,NON-SALICYLATE |
| GCN | 16965 |
| HICL Sequence Number | 001866 |
| HICL Sequence Number Description | ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | Henry Schein Acetaminophen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | Henry Schein, Inc. |
| 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 00404-0716-13 (00404071613)
| NDC Package Code | 0404-0716-13 |
|---|---|
| Billing NDC | 00404071613 |
| Package | 250 PACKET in 1 BOX (0404-0716-13) / 2 TABLET, FILM COATED in 1 PACKET (0404-0716-99) |
| Marketing Start Date | 2008-12-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a56a5ca1-578c-40cd-90cc-cc4c2dfec847 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg 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:
- 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
SPL UNCLASSIFIED SECTION
Directions
- do not use more than directed (see overdose warning)
Adults and children: (12 years and older)
- take 2 tablets every 4 to 6 hours while symptoms last
- do not take more than 6 tablets in 24 hours unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
Children under 12 years: Ask a doctor
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Henry Schein XS Acetaminophen Label
NDC #0404-0716-13
Henry Schein®
Extra Strength Acetaminophen
For the temporary relief of minor aches and pains associated with the headache, muscular aches, minor arthritis pain, common cold, toothache, menstrual cramps and for the reduction of fever.
Henry Schein Seal of Excellence®
This Package is for Households without Young Children.
Acetaminophen 500 mg
250 Packets/2 Tablets
Reorder
900-4690
INGREDIENTS AND APPEARANCE
| HENRY SCHEIN ACETAMINOPHEN
acetaminophen tablet, film coated |
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| Labeler - Henry Schein, Inc. (012430880) |
| Registrant - Unifirst First Aid Corporation (832947092) |