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NDC 49483-0342-00 ACETAMINOPHEN 500 mg/1 Details
ACETAMINOPHEN 500 mg/1
ACETAMINOPHEN is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by TIME CAP LABORATORIES, 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: 49483-0342-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 49483-0342 |
|---|---|
| Product ID | 49483-342_7d3e2e18-1dee-4000-e053-2a91aa0aeefe |
| Associated GPIs | |
| 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, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | TIME CAP LABORATORIES, 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 49483-0342-00 (49483034200)
| NDC Package Code | 49483-342-00 |
|---|---|
| Billing NDC | 49483034200 |
| Package | 100000 TABLET, FILM COATED in 1 CARTON (49483-342-00) |
| Marketing Start Date | 2018-12-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 2569383a-4a05-4ddb-852e-b37e487ffcde Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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Warnings;
Overdose warning: Taking more than the recommended dose (0verdose) may cause liver damage. in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1221) right way. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
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SPL UNCLASSIFIED SECTION
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Do not take more than directed (see overdosage warning) Adults and children 12 years and over: take 2 tablets (1,000 mg) every 6 hours while symptoms last; do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor; do not take for more than 10 days unless directed by a doctor Children under 12 years: Do not use this adult extra strength product in children under 12 years of age, this will provide more than the recommended dose (overdosage) of acetaminophen and may cause liver damage
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SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| ACETAMINOPHEN
acetaminophen tablet, film coated |
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| Labeler - TIME CAP LABORATORIES, INC (037052099) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| TIME CAP LABORATORIES, INC | 037052099 | manufacture(49483-342) | |