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

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Severe Allergy And Sinus Headache

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-543




FULL PRESCRIBING INFORMATION

(in each caplet)

Acetaminophen 325 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 5 mg

Pain reliever

Antihistamine

Nasal decongestant

  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • headache
  • minor aches and pains
  • nasal congestion
  • sinus congestion and pressure
  • 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
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle 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 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

corn starch, crospovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin

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® Severe Allergy Plus

Sinus Headache**

See New Warnings

Information

SEVERE ALLERGY

& SINUS HEADACHE

MAXIMUM STRENGTH

ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl

PAIN RELIEVER, ANTIHISTAMINE, NASAL DECONGESTANT

For Allergy Plus Sinus Pain & Pressure Relief

√ Sneezing

√ Itchy, Watery Eyes

√ Runny Nose

√ Sinus Congestion

√ Sinus Pain & Pressure

√ Sinus Headache

20 CAPLETS*

*Capsule-Shaped Tablets

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

50844                      REV0510C54309

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2010 CVS/pharmacy

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

Severe Allergy And Sinus Headache

Severe Allergy And Sinus Headache

Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-543
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
CROSPOVIDONE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
polyethylene glycol
povidone
SILICON DIOXIDE
STEARIC ACID
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
BLUE 16 mm 44;543 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 BLISTER PACK
2 NDC:59779-543-09 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2007-06-27


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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