ASSURED REGULAR STRENGTH ACETAMINOPHEN- acetaminophen capsule, gelatin coated
SPIRIT PHARMACEUTICALS LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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
Ask a doctor before use if the user has liver disease
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.
If pregnant or breast-feeding, ask a health professional before use.
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
| 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
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
