Label: NASAL DECONGESTANT- pseudoephedrine hydrochloride tablet
- NDC Code(s): 50844-112-08, 50844-112-15
- Packager: L.N.K. International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CI
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 tablet)
Pseudoephedrine HCl 30 mgClose
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
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 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- high blood pressure
- heart disease
- thyroid disease
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with fever
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
adults and children
12 years and older
take 2 tablets every 4 to 6 hours;
do not take more than 8 tablets in
children ages 6 to 12 years take 1 tablet every 4 to 6 hours;
do not take more than 4 tablets in
children under 6 years do not use this product in children
under 6 years of age
- Other information
- store at 25ºC (77º); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
- Inactive ingredients
croscarmellose sodium, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetinClose
- Questions or comments?
- Principal Display Panel
*Compare to the active ingredient in Sudafed® Congestion
Non-Drowsy / Maximum Strength
Pseudoephedrine HCl 30 mg
- Nasal & Sinus Congestion
- Sinus Pressure
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed® Congestion.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge NY 11788
Qualty Plus 44-112Close
- INGREDIENTS AND APPEARANCE
pseudoephedrine hcl tablet
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50844-112 Route of Administration ORAL DEA Schedule CI Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS FD&C YELLOW NO. 6 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS TITANIUM DIOXIDE TRIACETIN Product Characteristics Color RED Score no score Shape ROUND Size 8mm Flavor Imprint Code 44;112 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50844-112-15 1 in 1 CARTON 1 50 in 1 BLISTER PACK 2 NDC:50844-112-08 2 in 1 CARTON 2 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 08/25/1981 Labeler - L.N.K. International, Inc. (038154464)