NASAL DECONGESTANT PE MAXIMUM STRENGTH NON DROWSY- phenylephrine hcl tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

L.N.K. International, Inc.

INN (International Name):

PHENYLEPHRINE HYDROCHLORIDE

Composition:

PHENYLEPHRINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Nasal decongestant - temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies - temporarily relieves sinus congestion and pressure 

Authorization status:

OTC monograph final

Summary of Product characteristics

NASAL DECONGESTANT PE MAXIMUM STRENGTH NON DROWSY- PHENYLEPHRINE
HCL TABLET, FILM COATED
L.N.K. INTERNATIONAL, 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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QUALITY PLUS 44-453
_ACTIVE INGREDIENT (IN EACH TABLET)_
Phenylephrine HCl 10 mg
_PURPOSE_
Nasal decongestant
_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
heart disease
diabetes
thyroid disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland
WHEN USING THIS PRODUCT
DO NOT EXCEED RECOMMENDED DOSE.
STOP USE AND ASK A DOCTOR IF
nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with fever
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center (1-800-222-1222) right away.
_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: ask a doctor
_OTHER INFORMATION_
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS
TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 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, magnesium stearate,