Allergy and Sinus Headache description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Allergy and Sinus Headache

WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
L.N.K. International, Inc.




FULL PRESCRIBING INFORMATION

(in each caplet)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Pain reliever

Antihistamine

Nasal decongestant

  • temporarily relieves theses symptoms of hay fever and the common cold
  • runny nose
  • sneezing
  • headache
  • minor aches and pains
  • nasal congestion
  • temporarily relieves these additional symptoms of hay fever:
  • itching of the nose or throat
  • itchy, watery eyes

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
  • with any other product containing diphenhydramine, even one used on skin
  • 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehical or operating machinery
  • 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 use more than directed (see overdose warning)
  • adults and children 12 years and over
  • take 2 caplets every 4 hours
  • 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 59°-77°F in a dry place
  • see end flap for expiration date and lot number

corn starch, croscarmellose sodium, drospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, stearic acid, talc, titanium dioxide

1-800-426-9391

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

CVS®

pharmacy

Compare to the active ingredients in

Benadryl® Allergy Plus Sinus Headache*

See New Warnings Information

ALLERGY &

SINUS

HEADACHE

PAIN & PRESSURE RELIEF

PAIN RELIEVER / ANTIHISTAMINE / NASAL DECONGESTANT

Acetaminophen

Sinus Headache

Phenylephrine HCl

Sinus Congestion

Sinus Pressure

Diphenhydramine HCl

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

24 CAPLETS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2010 CVS/pharmacy

www.cvs.com                  1-800-shop-CVS

Allergy and Sinus Headache

Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-464
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 12.5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
CROSPOVIDONE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol
POLYVINYL ALCOHOL
povidone
SILICON DIOXIDE
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
GREEN 19 mm 44;464 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:59779-464-08 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-06-15


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.