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NDC 49483-0697-43 EXTRA STRENGTH ACETAMINOPHEN 500 mg/1 Details
EXTRA STRENGTH ACETAMINOPHEN 500 mg/1
EXTRA STRENGTH ACETAMINOPHEN is a ORAL TABLET 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: 49483-0697-43Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 49483-0697 |
|---|---|
| Product ID | 49483-697_d780e21d-d903-7c09-e053-2a95a90a3c57 |
| 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 | EXTRA STRENGTH ACETAMINOPHEN |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| 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 49483-0697-43 (49483069743)
| NDC Package Code | 49483-697-43 |
|---|---|
| Billing NDC | 49483069743 |
| Package | 400 TABLET in 1 BOTTLE (49483-697-43) |
| Marketing Start Date | 2022-02-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c9f80d24-bd05-e1ce-e053-2995a90aa646 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 of acetaminophen in 24 hours
• 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.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
- do not take more than directed (see overdose warning)
adults and children 12 years and over:
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets 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
INGREDIENTS AND APPEARANCE
| EXTRA STRENGTH ACETAMINOPHEN
acetaminophen tablet |
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| Labeler - TIME CAP LABORATORIES, INC. (037052099) |
| Registrant - TIME CAP LABORATORIES, INC. (037052099) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| MARKSANS PHARMA LIMITED | 925822975 | manufacture(49483-697) | |