NON-ASPIRIN SINUS CONGESTION AND PAIN
-
acetaminophen tablet
FRED'S, INC.
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Pain reliever
Nasal decongestant
for the temporary relief of:
headache
sinus congestion and pressure
minor aches and pains
nasal congestion
helps decongest sinus openings and passages
promotes sinus drainage
helps clear nasal passages
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
more than 12 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
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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
liver disease
diabetes
heart disease
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
taking the blood thinning drug warfarin
do not exceed recommended dosage
nervousness, dizziness, or sleeplessness occur
pain or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
These could be signs of a serious condition.
ask a health professional before use.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
do not take more than directed (see overdose warning)
adults and children 12 years and over
take 2 caplets every 4 hours
swallow whole – do not crush, chew, or dissolve
do not take more than 12 caplets in 24 hours
children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
store at controlled room temperature 15°-30°C (59°-86°F)
see end flap for expiration date and lot number
corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
FRED'S®
See New Warnings Information
Non-Aspirin
Sinus
Congestion & Pain
Pain Reliever/Nasal Decongestant
Non-Drowsy
Headache - Acetaminophen
Sinus Pressure
Nasal Congestion - Phenylephrine HCl
Pseudoephedrine Free
24 Cool Caplets
with Cool Blast Flavor
Tested Against The Active Ingredients in: TYLENOL® CONGESTION & PAIN DAYTIME*
Daytime
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Congestion & Pain Daytime.
50844 REV0310C46608
Fred's 44-466C
NON-ASPIRIN SINUS CONGESTION AND PAIN
acetaminophen and phenylephrine hcl tablet | ||||||||||||||||||||||||||||
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC MONOGRAPH NOT FINAL | part343 | 07/26/2005 |
Labeler - FRED'S, INC. (005866116) |
Establishment | |||
Name | Address | ID/FEI | Operations |
LNK International, Inc. | 038154464 | PACK |
Establishment | |||
Name | Address | ID/FEI | Operations |
LNK International, Inc. | 832867894 | MANUFACTURE |