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NDC 70518-2798-00 TYLENOL 325 mg/1 Details
TYLENOL 325 mg/1
TYLENOL 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: 70518-2798-00Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
NDC | 70518-2798 |
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Product ID | 70518-2798_d72366b3-c35b-12e9-e053-2a95a90aef8e |
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 | TYLENOL |
Proprietary Name Suffix | Regular Strength |
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 | 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 70518-2798-00 (70518279800)
NDC Package Code | 70518-2798-0 |
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Billing NDC | 70518279800 |
Package | 30 TABLET in 1 BLISTER PACK (70518-2798-0) |
Marketing Start Date | 2020-06-25 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 2b2a8fc2-79fc-4099-ba7c-cf8557598e13 Details
Uses
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. 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, which is the maximum daily amount
- 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 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 |
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children 6 years to under 12 years |
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children under 6 years | ask a doctor |
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL
DRUG: TYLENOL Regular Strength Regular Strength
GENERIC: Acetaminophen
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 70518-2798-0
COLOR: white
SHAPE: ROUND
SCORE: No score
SIZE: 10 mm
IMPRINT: TYLENOL;325
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- Acetaminophen 325mg in 1
INACTIVE INGREDIENT(S):
- sodium starch glycolate type a potato
- powdered cellulose
- magnesium stearate
INGREDIENTS AND APPEARANCE
TYLENOL
REGULAR STRENGTH
acetaminophen tablet |
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Labeler - REMEDYREPACK INC. (829572556) |