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NDC 70518-2805-01 Acetaminophen 500 mg/1 Details
Acetaminophen 500 mg/1
Acetaminophen is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by REMEDYREPACK 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: 70518-2805-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 70518-2805 |
|---|---|
| Product ID | 70518-2805_e671062b-deef-2489-e053-2995a90a4cb7 |
| Associated GPIs | 64200010000315 |
| 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 | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | REMEDYREPACK INC. |
| 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 70518-2805-01 (70518280501)
| NDC Package Code | 70518-2805-1 |
|---|---|
| Billing NDC | 70518280501 |
| Package | 56 TABLET in 1 BLISTER PACK (70518-2805-1) |
| Marketing Start Date | 2022-05-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7a66d692-422e-4633-b79b-160dc0d09248 Details
Uses
SPL UNCLASSIFIED SECTION
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.
- 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
Directions
- do not take more than directed (see overdose warning)
adults and children 12 years and over:
• take 2 tablets every 6 hours while symptoms last
• do not take more than 6 tablets 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: ask a doctor
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
DRUG: Acetaminophen
GENERIC: Acetaminophen
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 70518-2805-0
NDC: 70518-2805-1
NDC: 70518-2805-2
COLOR: white
SHAPE: ROUND
SCORE: Two even pieces
SIZE: 12 mm
IMPRINT: 54;27
PACKAGING: 30 in 1 BLISTER PACK
PACKAGING: 56 in 1 BLISTER PACK
PACKAGING: 28 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- ACETAMINOPHEN 500mg in 1
INACTIVE INGREDIENT(S):
- STARCH, CORN
- STEARIC ACID
- POVIDONE K30
- SODIUM STARCH GLYCOLATE TYPE A POTATO
INGREDIENTS AND APPEARANCE
| ACETAMINOPHEN
acetaminophen tablet |
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| Labeler - REMEDYREPACK INC. (829572556) |