DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT- acetaminophen and phenylephrine hydrochloride capsule, liquid filled
Freds Inc
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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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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 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.
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- difficulty in urinating due to an enlarged prostate gland
Stop use and ask a doctor if
- new symptoms occur
- redness or swelling is present
- you get nervous, dizzy or sleepless
- fever gets worse or lasts more than 3 days
- symptoms do not get better within 7 days or are accompanied by a fever
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose could cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed (see Overdose warning)
- do not exceed 4 doses in 24 hours
- when using other Day Time and Night Time products, carefully read each label to ensure correct dosing
| adults and children 12 years of age and over | take 2 softgels with water every 4 hours |
| children 4 to under 12 years of age | ask a doctor |
| children under 4 years of age | do not use |
Inactive ingredients
FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink
Principal Display Panel
Non-Drowsy
Day Time Sinus
Acetaminophen 325 mg, Phenylephrine HCl 5 mg
Pain Reliever, Nasal Decongestant
Relieves:
Sinus Pain
Sinus Headache
Sinus Congestion
Softgels
Compare to the active ingredients in Vicks® DayQuil® Sinex®*
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® Sinex®.
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION
DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
| DAY TIME SINUS
PAIN RELIEVER, NASAL DECONGESTANT
acetaminophen and phenylephrine hydrochloride capsule, liquid filled |
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| Labeler - Freds Inc (005866116) |
| Registrant - P and L Development of New York Corporation (800014821) |