ASSURED REGULAR STRENGTH ACETAMINOPHEN
- Dosage form
- CAPSULE, GELATIN COATED
- Labeler
- SPIRIT PHARMACEUTICALS LLC
- Label updated
- 2016-08-03
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN
Label information
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
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (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
- do not give this product to children for the pain of arthritis unless directed by a doctor
Label information
Ask a doctor before use if the user has liver disease
Label information
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Label information
If pregnant or breast-feeding, ask a health professional before use.
Label information
Keep out of reach of children.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children 6-11 years |
|
| 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
Label information
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
[Image in the official label — see DailyMed source]
DailyMed Set ID: 19756c2a-822c-47d0-8b61-85dc026a12a7 · Version 1
NDC: 68210-0012