RxNorm Names
Review RxNorm Normal Forms
NASAL DECONGESTANT PE
(phenylephrine hcl)
tablet, coated
[FRED'S, INC.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=490f7710-49c8-4bf5-a498-de058f026bb9| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
Warnings
Do not use
- 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
- diabetes
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
Directions
- adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
- children under 12 years: do not use this product in children under 12 years of age
Other information
- store at controlled room temperature 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
croscarmellose sodium, dextrose, monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesiums stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide
Principal display panel
FRED'S®
Maximum Strength
Nasal Decongestant PE
Nasal Decongestant
Non-Drowsy
Phenylephrine HCl 10 mg
Relieves:
• Nasal & Sinus Congestion
• Sinus Pressure
Pseudoephedrine Free
18 Tablets - 10 mg Each
Tested Against The Active Ingredient in: SUDAFED PE®*
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 Sudafed PE®.
50844 REV0810C45344
Fred's 44-453
| NASAL DECONGESTANT PE
phenylephrine hcl tablet, coated |
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| Labeler - FRED'S, INC. (005866116) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 038154464 | PACK(55315-453) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 832867894 | MANUFACTURE(55315-453) | |
