Active Ingredients And Purpose
Active ingredient (in each softgel)
Acetaminophen 325 mg
Purpose
Pain reliever/fever reducer
ASSURED™ REGULAR STRENGTH ACETAMINOPHEN
- Set ID
- 19756c2a-822c-47d0-8b61-85dc026a12a7
- Manufacturer
- SPIRIT PHARMACEUTICALS LLC | MEDGEL PVT LTD
- Effective date
- 2016-08-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:46:46
Key Label Information
Uses
Uses
temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
Warnings
Warnings
Directions And Dosage
Directions
do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 softgels every 4 to 6 hours while symptoms last do not take more than 10 softgels in 24 hours do not use for more than 10 days unless directed by a doctor children 6-11 years take 1 softgel every 4 to 6 hours while symptoms last do not take more than 5 softgels in 24 hours do not use for more than 5 days unless directed by a doctor children under 6 years ask a doctor
Other Label Information
Other information
store between 20-25°C (68-77°F)
Inactive ingredients
FD&C red # 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Questions or comments?
Call 1-888-333-9792
PRINCIPAL DISPLAY PANEL - 10 Softgel Bottle Carton
ASSURED ™ COMPARE TO ACTIVE INGREDIENT IN TYLENOL ® REGULAR STRENGTH* REGULAR STRENGTH Acetaminophen Acetaminophen 325 mg Pain Reliever / Fever Reducer Actual Size 10 softgels
Products
- ASSURED REGULAR STRENGTH ACETAMINOPHEN
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Complete SPL Sections
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each softgel)
Acetaminophen 325 mg
Purpose
Pain reliever/fever reducer
Uses
temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever
Warnings
Directions
do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 softgels every 4 to 6 hours while symptoms last do not take more than 10 softgels in 24 hours do not use for more than 10 days unless directed by a doctor children 6-11 years take 1 softgel every 4 to 6 hours while symptoms last do not take more than 5 softgels in 24 hours do not use for more than 5 days unless directed by a doctor children under 6 years ask a doctor
Other information
store between 20-25°C (68-77°F)
Inactive ingredients
FD&C red # 40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Questions or comments?
Call 1-888-333-9792
SPL UNCLASSIFIED SECTION
DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC. 500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
PRINCIPAL DISPLAY PANEL - 10 Softgel Bottle Carton
ASSURED ™ COMPARE TO ACTIVE INGREDIENT IN TYLENOL ® REGULAR STRENGTH* REGULAR STRENGTH Acetaminophen Acetaminophen 325 mg Pain Reliever / Fever Reducer Actual Size 10 softgels
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/19756c2a-822c-47d0-8b61-85dc026a12a7/da770899-4313-4d63-874e-34ef0ca63923.xml
- XML SHA-256
- 0ada0d4e2711e50971d29540a79ebe9a3b12d0a479dd6b9cfdba3c417e0106fe
- XML bytes
- 30019
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | acetaminophen-01.jpg | 2016-08-12 |
| otc | da770899-4313-4d63-874e-34ef0ca63923.xml | 2016-08-12 |