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NDC 49483-0699-26 Acetaminophen 650 mg/1 Details
Acetaminophen 650 mg/1
Acetaminophen is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by TIME CAP LABORATORIES, INC.. The primary component is ACETAMINOPHEN.
Product Information
NDC | 49483-0699 |
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Product ID | 49483-699_eb0bcd1a-2f6b-5e5e-e053-2995a90ab995 |
Associated GPIs | 64200010000420 |
GCN Sequence Number | 022123 |
GCN Sequence Number Description | acetaminophen TABLET ER 650 MG ORAL |
HIC3 | H3E |
HIC3 Description | ANALGESIC/ANTIPYRETICS,NON-SALICYLATE |
GCN | 16910 |
HICL Sequence Number | 001866 |
HICL Sequence Number Description | ACETAMINOPHEN |
Brand/Generic | Generic |
Proprietary Name | Acetaminophen |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Acetaminophen tablet extended release |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, EXTENDED RELEASE |
Route | ORAL |
Active Ingredient Strength | 650 |
Active Ingredient Units | mg/1 |
Substance Name | ACETAMINOPHEN |
Labeler Name | TIME CAP LABORATORIES, INC. |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA215486 |
Listing Certified Through | 2024-12-31 |
Package
Package Images









NDC 49483-0699-26 (49483069926)
NDC Package Code | 49483-699-26 |
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Billing NDC | 49483069926 |
Package | 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-26) |
Marketing Start Date | 2022-11-07 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cd4d0ad4-7206-94c8-e053-2a95a90aaa14 Details
SPL UNCLASSIFIED SECTION
Uses
For Arthritis Pain
temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- premenstrual and menstrual cramps
- the common cold
- headache
- toothache
temporarily reduces fever
For Muscle Aches & Pains
temporarily relieves minor aches and pains due to:
- muscular aches
- backache
- minor pain of arthritis
- toothache
- premenstrual and menstrual cramps
- headache
- the common cold
temporarily reduces fever
SPL UNCLASSIFIED SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets 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.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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Directions
For Arthritis Pain
Do not take more than directed. See overdose warning
adults:
- take 2 caplets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
under 18 years of age: ask a doctor
For Muscle Aches & Pains
Do not take more than directed. See overdose warning
adults and children 12 years and over:
- take 2 caplets every 8 hours with water
- swallow whole; do not crush, chew, split or dissolve
- do not take more than 6 caplets in 24 hours
- do not use for more than 10 days unless directed by a doctor
children under 12 years: do not use
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet extended release tablet, extended release |
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MUSCLE ACHES AND PAINS ACETAMINOPHEN EXTENDED RELEASE
acetaminophen tablet, extended release |
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Labeler - TIME CAP LABORATORIES, INC. (037052099) |
Registrant - TIME CAP LABORATORIES, INC. (037052099) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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MARKSANS PHARMA LIMITED | 925822975 | manufacture(49483-699, 49483-704) |